Form FDA 3626 FDA 3626 A Guide for the Submission of Initial Reports on Diagnos

Electronic Products Requirements

3626 DX Product Report form

Reporting for Electronic Products

OMB: 0910-0025

Document [pdf]

Download: pdf | pdf

Form Approved: OMB No. 0910-0025
Expiration Date: January 31, 2017

FORM FDA 3626 (1/14)
A Guide for the Submission of Initial Reports on
Diagnostic X-Ray Systems and Their Major Components

Public reporting burden for this collection of information is estimated to average 24 hours per
response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paper Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
*Please do NOT send your completed document to this PRA Staff email address.*
An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number.

This guidance was written prior to the February 27, 1997 implementation of FDA’s
Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person
and does not operate to bind FDA or the public. An alternative approach may be used if
such approach satisfies the requirements of the applicable statute, regulations, or both.
This guidance will be updated in the next revision to include the standard elements of GGP’s.

More industry guidance and assistance can be found at the FDA homepage, see:
http://www.fda.gov/Radiation-EmittingProducts/ .

Send your completed report to:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER – WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
Questions about reporting and suggestions for changes to this guide may be sent to the above
address or may be discussed by calling 1-800-638-2041.

FORM FDA 3626 (1/14)

A Guide for the Submission of
Initial Reports on Diagnostic X-Ray Systems
and Their Major Components

Published by
Office of Compliance
X-Ray Products Branch

February 1973
Revised January 1982

The reporting and/or recordkeeping requirements contained herein
have been approved by the Office of Management and Budget in
accordance with the Federal Reports Act of 1942.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Silver Spring, MD 20993

FORM FDA 3626 (1/14)

This page is deliberately blank.

FORM FDA 3626 (1/14)

PAGE
CONTENTS
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
TABLE 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
PART 100 - IDENTIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Section 101.0 - Report Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Section 102.0 - Product Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PART 200 - COMPONENT DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Section 201.0 - Tube Housing Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Section 202.0 - Beam-Limiting Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Section 203.0 - X-Ray Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Section 204.0 - High-Voltage Generators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Section 205.0 - Spot-Film Devices and Image Intensifiers . . . . . . . . . . . . . . . . . . . . . . . . . 13
Section 206.0 - Tables, Cassette Holders, Film Changers and Cradles . . . . . . . . . . . . . . 14
Section 207.0 - Cephalometric Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Section 208.0 - Image Receptor Support Devices for Mammographic
X-Ray Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
PART 300 - QUALITY CONTROL TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Section 301.0 - Leakage Radiation From the Diagnostic Source Assembly . . . . . . . . . . . 17
Section 302.0 - Beam Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Section 303.0 - Aluminum Equivalence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Section 304.0 - Standby Radiation From Capacitor Energy Storage Equipment . . . . . . . 23
Section 305.0 - Fluoroscopic Entrance Exposure Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Section 306.0 - Primary Protective Barrier Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Section 307.0 - Reproducibility and Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Section 308.0 - Radiation From Components Other Than the Diagnostic
Source Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Section 309.0 - Peak Tube Potential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Section 310.0 - Tube Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Section 311.0 - Tube Current-Exposure Time Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Section 312.0 - Exposure Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Section 313.0 - Automatic Exposure Control Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Section 314.0 - Automatic Exposure Control Minimum Exposure Time . . . . . . . . . . . . . . 43
Section 315.0 - Illuminance of Light Localizers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Section 316.0 - Alignment of Visually Defined X-Ray Fields and Contrast of
Light Defined X-Ray Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Section 317.0 - Alignment of the Center of the Radiographic X-Ray
Field With the Center of the Image Receptor . . . . . . . . . . . . . . . . . . . . . . . 49
Section 318.0 - Radiographic X-Ray Field Size and Image Receptor Size . . . . . . . . . . . 51
Section 319.0 - X-Ray Field Size Determination for Fixed SID/Image
Receptor Size Radiographic Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Section 320.0 - Alignment of the X-Ray Field and Spot-Film Cassette . . . . . . . . . . . . . . . 55
Section 321.0 - Alignment of Edges of the X-Ray Field With the Edges
of the Fluoroscopic Image Receptor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Section 322.0 - X-Ray Field Size Determination for Dental Equipment
Using Intraoral Image Receptors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
i
FORM FDA 3626 (1/14)

Section 323.0 - X-Ray Field Size Determination for Mammographic
Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Section 324.0 - X-Ray Field Size Determination for Radiographic
Equipment Not Listed in 318.0, 319.0, 320.0, 321.0,
322.0 or 323.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Section 325.0 - Transmission Limit for Image Receptor Support
Devices for Mammographic X-Ray Systems . . . . . . . . . . . . . . . . . . . . . . . 65
PART 400 - COMMON ASPECTS

Section 401.0 - Instrumentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Section 402.0 - Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

ii
FORM FDA 3626 (1/14)

A GUIDE FOR THE SUBMISSION OF INITIAL REPORTS ON DIAGNOSTIC
X-RAY SYSTEMS AND THEIR MAJOR COMPONENTS
INTRODUCTION
This guide outlines for a manufacturer, a format for the presentation of initial and
supplemental reports on diagnostic x-ray systems and their major components which
are subject to the Performance Standard 21 CFR 1020.30,1020.31, and 1020.32.
The diagnostic x-ray equipment subject to the standard includes: tube housing
assemblies, x-ray controls, x-ray high voltage generators, tables, cradles, film
changers, cassette holders, beam-limiting devices, spot film devices, image
intensifiers, cephalometric devices, image receptor support devices for
mammographic x-ray systems, and diagnostic x-ray systems incorporating one or
more previously listed components.
The subject reporting guide is an attempt to identify the pertinent information
needed by the Bureau of Radiological Health (BRH) to fulfill its delegated
responsibilities under the Radiation Control for Health and Safety Act of 1968 (PL
90-602). It is also believed that identification of this information will make the
manufacturer's reporting task somewhat easier since, after the initial organization of
the material, the manufacturer will not be obligated to prepare and submit such
voluminous reports as in the past. Manufacturers may elect to continue using a
previous version of the Reporting Guide when supplementing old reports. It is
required that all new initial reports follow this revision of the Reporting Guide
consistent with 21 CFR 1002.7 (b).
This guide asks for information in four parts. PART 100 - IDENTIFICATION,
containing two sections, asks for information with regard to identification, labels and
instructions pertaining to the manufacturer's equipment. The manufacturer must
answer all questions in sections 101.0 and 102.0 of this part. PART 200 COMPONENT DESCRIPTION, containing eight sections, ask for information
pertaining to specific performance characteristics of the equipment. The
manufacturer must answer all questions in the section(s) of this part that are
identified by the component type(s) reported in PART 100. PART 300 - QUALITY
CONTROL TESTING, containing twenty-five sections, ask for presentations of
prototype, production and assembler test methods and results. Sections to be
answered in this part are identified in sections 201 through 208 of PART 200 and in
Table 1. PART 400 - COMMON ASPECTS, containing two sections, asks for test
instrument specifications and sampling protocols. The manufacturer must answer all
questions in the applicable paragraphs of section 401.0 and, when appropriate, all
questions in section 402.0 of this part.
Manufacturers are encouraged to submit a “Common Aspects Report” in order
to simplify their reporting obligations. The Common Aspects Report is a separate
initial report that incorporates a description of test methods, instrumentation, and
sampling plans common to several models. This Common Aspects Report is not
intended as a means for certification of any specific model. Currently, separate
initial reports from the same manufacturer often provide identical descriptions of
the quality control program. Such duplication is costly and entails extra effort for
iii
FORM FDA 3626 (1/14)

both the manufacturer and the Bureau. By development of a Common Aspects Report,
standardized test methods, instrumentation, and sampling plans may be collected into
one report. Initial reports for specific models can now reference applicable sections of
the Common Aspects Report. For example, an initial report on an x-ray control must
include responses to the appropriate sections of PART 100-IDENTIFICATION and
PART 200-COMPONENT DESCRIPTION, however, information with respect to test
methods in PART 300-QUALITY CONTROL TESTING and also PART 400-COMMON
ASPECTS may be provided by referencing the Common Aspects Report. Sample test
data solicited in PART 300 must still be included in the initial report.
Manufacturers may simplify reporting of the test data by grouping similar models
within one report. For example, all x-ray tables with the same tabletop material may
be reported in the same initial report. Whenever several models are related by
design and/or performance, presentation of test results in PART 300-QUALITY
CONTROL TESTING may apply to all models without reference to each model
designation. Future reporting of similar models would not require sample test results
when specifically referenced to results presented in an earlier initial report or report
supplement. In each case, the manufacturer must clarify his intent to group similar
models for a given test in PART 300, provide the technical basis for this grouping,
and affirm test results comparability.
Table 1 provides a reference to aid the manufacturer in readily identifying which
sections of each part he must complete for the particular component(s) that he is
reporting. To use the table, the component is found in the left hand column and the
sections within each part to be completed for that component are found in the
columns to the right.
All material shall be submitted in the English language or with an accurate
attached English translation. Definitions for technical terms used in this guide may
be found on page vii.

iv
FORM FDA 3626 (1/14)

Table 1. - Applicable sections required to be completed for each component type
Applicable sections

Component type
PART 100

PART 200

PART 300

PART 400

Tube Housing Assembly

101.0,
102.0

201.0

301.0,
302.0

401.0,
(402.0 as
applicable)

Beam-Limiting Device
All (answer these sections
and those below as
appropriate)

101.0,
102.0

202.0

301.0,
302.0

401.0,
(402.0 as
applicable)

304.0

401.0,
(402.0 as
applicable)

Positive beam limitation
capability

315.0, 316.0
317.0, 318.0

401.0,
(402.0 as
applicable)

Fixed SID/fixed image
Receptor size use

319.0,
(315.0, 316.0,
317.0 as
applicable)

401.0,
(402.0 as
applicable)

Diagnostic source
assembly used in capacitor
energy storage equpiment

Spot-film use

320.0

401.0,
(402.0 as
applicable)

Fluoroscopic use

321.0

401.0,
(402.0 as
applicable)

Dental use

322.0

401.0,
(402.0 as
applicable)

Mammographic use

323.0

401.0,
(402.0 as
applicable)

324.0,
(315.0, 316.0,
317.0 as
applicable)

Other uses

X-Ray Control
All (answer these sections
and those below as
appropriate)

101.0,
102.0

203.0

v
FORM FDA 3626 (1/14)

307.0

401.0,
(402.0 as
applicable)
401.0,
(402.0 as
applicable)

kVp selection capability

309.0

401.0,
(402.0 as
applicable)

mA selection capability

310.0

401.0,
(402.0 as
applicable)

mAs selection capability

311.0

401.0,
(402.0 as
applicable)

Time selection capability

312.0

401.0,
(402.0 as
applicable)

Automatic exposure control

313.0,
314.0

401.0,
(402.0 as
applicable)

Fluoroscopy selection
capability

305.0

401.0,
(402.0 as
applicable)

High-Voltage Generator

101.0,
102.0

204.0

308.0

401.0,
(402.0 as
applicable)

Spot-Film Device

101.0,
102.0

205.0

306.0

401.0,
(402.0 as
applicable)

Image Intensifier

101.0,
102.0

205.0

306.0,
308.0

401.0,
(402.0 as
applicable)

Tables, Cassette Holders,
Cradles, Film Changers

101.0,
102.0

206.0

303.0

401.0,
(402.0 as
applicable)

Cephalometric Device
Fixed SID

101.0,
102.0

207.0

319.0

401.0,
(402.0 as
applicable)

101.0,
102.0

207.0

324.0

401.0,
(402.0 as
applicable)

101.0,
102.0

208.0

325.0

401.0,
(402.0 as
applicable)

Variable SID

Mammographic Image Receptor
Support Device

vi
FORM FDA 3626 (1/14)

DEFINITIONS
As used in this guide and 21 CFR 1020.30, 1020.31 and 1020.32, the following
definitions apply:
(1)

“Accessible surface” means the external surface of the enclosure or housing
provided by the manufacturer.

(2)

“Aluminum equivalent” means the thickness of aluminum (type 1100 alloy)
affording the same attenuation, under specified conditions, as the material in
question.

(3)

“Assembler” means any person engaged in the business of assembling,
replacing, or installing one or more components into an x-ray system or
subsystem

(4)

“Attenuation block” means a block or stack, having dimensions 20 centimeters
by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy or
aluminum alloy having equivalent attenuation.

(5)

“Automatic exposure control” means a device which automatically controls one
or more technique factors in order to obtain at a preselected location(s) a
required quantity of radiation.

(6)

"Beam axis" means a line from the source through the centers of the x-ray
fields.

(7)

“Beam-limiting device” means a device which provides a means to restrict the
dimensions of the x-ray field.

(8)

“Coefficient of variation” means the ratio of the standard deviation to the mean
value of a population of observations. It is estimated using the following
equation:

s
X

= 1
X

1/2

(Xi - X )
n-1

i=1

where
s = Estimated standard deviation of the population
X = Mean value of observations in sample
Xi = ith observation sampled
n = Number of observations sampled

(9)

“Control panel” means that part of the x-ray control upon which are mounted
the switches, knobs, pushbuttons, and other hardware necessary for manually
setting the technique factors.
(10) “Cooling curve” means the graphical relationship between heat units stored
and cooling time.
(11) “Diagnostic source assembly” means the tube housing assembly with a beamlimiting device attached.
vii
FORM FDA 3626 (1/14)

(12) “Diagnostic x-ray system” means an x-ray system designed for irradiation of
any part of the human body for the purpose of diagnosis or visualization.
(13) “Equipment" means x-ray equpiment.
(14) “Exposure” means the quotient of dQ by dm where dQ is the absolute value of
the total charge of the ions of one sign produced in air when all the electrons
(negatrons and positrons) liberated by photons in a volume element of air
having mass dm are completely stopped in air.
(15) “Field emission equipment” means equipment which uses an x-ray tube in
which electron emission from the cathode is due solely to the action of an
electric field.
(16) “Fluoroscopic imaging assembly” means a subsystem in which x-ray photons
produce a fluoroscopic image. It includes the image receptor(s) such as the
image intensifier and spot-film device, electrical interlocks, if any, and
structural material providing linkage between the image receptor and
diagnostic source assembly.
(17) “General purpose radiographic x-ray system” means any radiographic x-ray
system which, by design, is not limited to radiographic examination of specific
anatomical regions.
(18) “Half-value layer, HVL” means the thickness of specified material which
attenuates the beam of radiation to an extent such that the exposure rate is
reduced to one-half of its original value. In this definition the contribution of all
scattered radiation, other than any which might be present initially in the beam
concerned, is deemed to be excluded.
(19) “Image receptor” means any device, such as a fluorescent screen or
radiographic film, which transforms incident x-ray photons either into a visible
image or into another form which can be made into a visible image by further
transformations.
(20) “Leakage radiation” means radiation emanating from the diagnostic source
assembly except for:
(i)

The useful beam and

(ii)

Radiation produced when the exposure switch or timer is not activated.

(21) “Leakage technique factors” means the technique factors associated with the
tube housing assembly which are used in measuring leakage radiation. They
are defined as follows:
(i) For tube housing assemblies intended for capacitor energy storage
equipment, the maximum-rated peak tube potential and the maximum-rated
number of exposures in an hour for operation at the maximum-rated peak tube
potential with the quantity of charge per exposure being 10 millicoulombs
(mAs) or the minimum obtainable from the unit, whichever is larger.
(ii) For tube housing assemblies intended for field emission equipment rated
for pulsed operation, the maximum-rated peak tube potential and the
maximum-rated number of x-ray pulses in an hour for operation at the
maximum-rated peak tube potential.

viii
FORM FDA 3626 (1/14)

(iii) For all other tube housing assemblies, the maximum-rated peak tube
potential and the maximum-rated continuous tube current for the maximumrated peak tube potential.
(22) “Light field” means that area of the intersection of the light beam from the
beam-limiting device and one of the set of planes parallel to and including the
plane of the image receptor whose perimeter is the locus of points at which the
illumination is one-fourth of the maximum in the intersection.
(23) “Line-voltage regulation” means that difference between the no-load and the
load line potentials expressed as a percent of the load line potential; that is,
Percent line-voltage regulation = 100 (Vn - Vi)/ Vi
where:
Vn = No-load line potential and
Vi = Load line potential.
(24) “Maximum line current” means the rms current in the supply line of an x-ray
machine operating at its maximum rating.
(25) “Peak tube potential” means the maximum value of the potential difference
across the x-ray tube during an exposure.
(26) “Primary protective barrier” means the material, excluding filters, placed in the
useful beam to reduce the radiation exposure for protection purposes.
(27) “Rated line voltage” means the range of potentials, in volts, of the supply line
specified by the manufacturer at which the x-ray machine is designed to
operate.
(28) “Rated output current” means the maximum allowable load current of the x-ray
high-voltage generator.
(29) “Rated output voltage” means the allowable peak potential, in volts, at the
output terminals of the x-ray high-voltage generator.
(30) "Rating” means the operating limits specified by the manufacturer.
(31) “Recording” means producing a permanent form of an image resulting from
x-ray photons (e.g., film, videotape).
(32) “Response time” means the time required for an instrument system to reach 90
percent of its final reading when the radiation-sensitive volume of the
instrument system is exposed to a step change in radiation flux from zero
sufficient to provide a steady state midscale reading.
(33) “Source” means the focal spot of the x-ray tube.
(34) “Source-image receptor distance, (SID)” means the distance from the source to
the center of the input surface of the image receptor.
(35) “Stationary equipment” means equipment which is installed in a fixed location.

ix
FORM FDA 3626 (1/14)

(36) “Technique factors” means the conditions of operation. They are specified as
follows:
(i) For capacitor energy storage equipment, peak tube potential in kV and
quantity of charge in mAs;
(ii) For field emission equipment rated for pulsed operation, peak tube
potential in kV, and number of x-ray pulses; and
(iii) For all other equipment, peak tube potential in kV, and either tube current
in mA and exposure time in seconds, or the product of tube current and
exposure time in mAs.
(37) “Tube” means an x-ray tube, unless otherwise specified.
(38) “Tube housing assembly” means the tube housing with tube installed. It
includes high-voltage and/or filament transformers and other appropriate
elements when they are contained within the tube housing.
(39) “Tube rating chart” means the set of curves which specify the rated limits of
operation of the tube in terms of the technique factors.
(40) “Useful beam” means the radiation which passes through the tube housing port
and the aperture of the beam-limiting device when the exposure switch or timer
is activated.
(41) “Variable-aperture beam-limiting device” means beam-limiting device
which has capacity for stepless adjustment of the x-ray field size at a
given SID.
(42) “Visible area" means that portion of the input surface of the image receptor
over which incident x-ray photons are producing a visible image.
(43) “X-ray control” means a device which controls input power to the x-ray
high-voltage generator and/or the x-ray tube. It includes equipment such as
timers, phototimers, automatic brightness stabilizers, and similar devices,
which control the technique factors of an x-ray exposure.
(44) “X-ray equipment” means an x-ray system, subsystem, or component thereof.
(45) “X-ray field” means that area of the intersection of the useful beam and any
one of the set of planes parallel to and including the plane of the image
receptor, whose perimeter is the locus of points at which the exposure rate is
one-fourth of the maximum in the intersection.
(46) “X-ray high-voltage generator” means a device which transforms electrical
energy from the potential supplied by the x-ray control to the tube operating
potential. The device may also include means for transforming alternating
current to direct current, filament transformers for the x-ray tube(s),
high-voltage switches, electrical protective devices, and other appropriate
elements.
(47) “X-ray system” means an assemblage of components for the controlled
production of x rays. It includes minimally an x-ray high-voltage generator, an
x-ray control, a tube housing assembly, a beam-limiting device, and the
necessary supporting structures. Additional components which function with
the system are considered integral parts of the system.
x
FORM FDA 3626 (1/14)

(48) “X-ray subsystem” means any combination of two or more components of an
x-ray system for which there are requirements specified in §§ 1020.30,
1020.31 and 1020.32.
(49) “X-ray tube” means any electron tube which is designed for the conversion of
electrical energy into x-ray energy.
(50) “Radiation therapy simulation system" means a fluoroscopic x-ray system
intended for localizing the volume to be exposed during radiation therapy and
confirming the position and size of the therapeutic irradiation field.
(51) “Spot-film device” means a device intended to transport and/or position a
radiographic image receptor between the x-ray source and fluoroscopic image
receptor. It includes a device intended to hold a cassette over the input end of
an image intensifier for the purpose of making a radiograph.
(52) “Image intensifier” means a device, installed in its housing, which
instantaneously converts an x-ray pattern into a corresponding light image of
higher energy density.
(53) “Cephalometric device” means a device intended for the radiographic
visualization and measurement of the dimensions of the human head.
(54) “Image receptor support” means, for mammographic systems, that part of the
system designed to support the image receptor in a horizontal plane during a
mammographic examination.

xi
FORM FDA 3626 (1/14)

This page is deliberately blank.

FORM FDA 3626 (1/14)

PART 100 - IDENTIFICATION
101.0

REPORT IDENTIFICATION
Please confirm that this report is subjected pursuant to paragraph (c)(1)
of section 1002.61. State each of following:
Report type (initial or supplement to BRH Accession #

)

Name of Manufacturer
Name of Submitter
Corresponding Official
102.0

PRODUCT IDENTIFICATION

102.1

Give the model designation for any of the following components that you
are certifying in this report (tube housing assemblies, x-ray controls, x-ray
high-voltage generators, tables, cradles, film changers, cassette holders,
beam-limiting devices, spot-film devices, image intensifiers, cephalometric
devices, and image receptor support devices for mammographic x-ray
systems).
Certifiable component type

Model designation

102.2 If you combine components under a single certification label pursuant to
21 CFR 1020.30(c), provide the model number for any combination that you
are certifying in this report. High voltage generators contained within tube
housings, beam-limiting devices contained within tube housing, beam-limiting
devices which are integral parts of tube housings, and high voltage
generators and x-ray controls which are inseparable and housed jointly are
the only combinations that may be combined under a single certification label.
Other combinations may be authorized by the Bureau of Radiological Health
upon application by their manufacturer. Authorization for single labeling may
be granted only for inseparable combinations of components that are
contained within a single housing.
Certifiable combination type

1
FORM FDA 3626 (1/14)

Model designation

102.3

If any of the models reported in 102.1 and/or 102.2 are sold under name(s)
other than your own, provide the model designation and the name and
address of each company under whose name the model is sold.

102.4

For every model listed under 102.1 and 102.2, provide an exact replica of all
labels complete with the following:
a.

the certification statement;

the name and address of the manufacturer (or the individual or company
under whose name it is sold);

the date and place of manufacture; and

the model designation and sample serial number;

the manufacturer, model designation and sample serial number of the
tube insert if applicable.

In addition, the standard requires that the labels be permanently affixed,
legible, and accessible to view. Provide a drawing or photograph of
each certifiable component and/or combination showing the attached
label. Attach all of the requested information under this paragraph
(102.4) as APPENDIX A.

102.5 For each complete x-ray system or subsystem that incorporates components
being certified in this report, give the system/subsystem designation.
Also, for each system/subsystem, identify each certifiable component by
component type, model designation, and manufacturer. Example: If you
market an x-ray system and call it “Super 100,” and it consists of Tube
Housing Assembly X, High-voltage Generator Y, X-Ray Control Z, and BeamLimiting Device A; you would list “Super 100” and the component type, model
designation, and manufacturer of the four certifiable components that
comprise the system.
Use the following or a similar format:
System designation:
Component type

Model designation

Manufacturer

102.6 Attach “Information to Assemblers” (1020.30(g)) as APPENDIX B. Include
each of the following:
a.

assembly and testing instructions necessary for assuring compliance to
the Performance Standard.

compatibility specifications referenced in 21 CFR 1020.30(g).
2

FORM FDA 3626 (1/14)

102.7 Attach “Information to Users” (1020.30(h)) as APPENDIX C. Include each of
the following:
a.

operating instructions;

picture or drawing of product;

product specifications;

cautionary statements for 21 CFR 1020.32(a)(1) and (f) if applicable;
and

maintenance schedule.

3
FORM FDA 3626 (1/14)

PART 200 - COMPONENT DESCRIPTION
201.0

TUBE HOUSING ASSEMBLY
This section should be completed for each tube housing assembly listed in
section 102.1 of PART 100 and any combination listed in section 102.2 of
PART 100 that contains a tube housing assembly as an integral part thereof.

201.1

State the maximum rated peak tube potential for each model tube housing
assembly.

201.2

For each model intended for use on a general purpose x-ray system, cite
the specific paragraph(s) in your instructions to assemblers that lists
compatible tube stands and/or other equipment necessary for indication
(as required under 21 CFR 1020.31(e)(1)(i), (g)(2), and 1020.32(b)(1)(ii),
(b)(2)(iii)) of:
a.

the perpendicularity of the beam axis to the image receptor, and

the SID.

201.3

If you reload tube housing assemblies, describe how you remove, deface, or
cover the original labels on the assembly.

201.4

Answer the questions in sections 301.0 and 302.0, PART 300.

4
FORM FDA 3626 (1/14)

202.0 BEAM-LIMITING DEVICES
This section should be completed for each beam-limiting device listed in
section 102.1 of PART 100 and any combination listed in section 102.2 of
PART 100 that contains a beam-limiting device as an integral part thereof.
202.1 List all use or applications for which each model is intended, such as: general
purpose radiographic, general purpose fluoroscopic, combination radiographic
and fluoroscopic, tomographic, angiographic, podiatric, urologic,
mammographic, chest, head-neck, panoramic, intraoral (general purpose
dental), cephalometric, and computerized tomography.
202.2

202.3

Dental (excluding cephalometric and panoramic)
a.

If the beam-limiting device is used with an intraoral image receptor,
specify the minimum source-to-skin distance (SSD) and the dimensions
and geometric configuration (e.g., circular, rectangular, or elliptical)
of the x-ray field produced by each beam-limiting device at its
minimum SSD.

If the beam-limiting device is used with an extraoral image receptor,
answer the questions in 202.9 of this section.

Answer the questions in section 322.0, PART 300.

General Purpose Radiographic - mobile and stationary (excluding
mammographic attachments, spot-film devices, and dental units)
a.

Is the adjustment for the size of the x-ray field stepless?

Provide a statement of the minimum x-ray field size at 100 centimeters
SID for the tube housings for which the beam-limiting device is
designed.

If the beam-limiting device is used in mobile or portable x-ray systems,
state the minimum SSD.

If the beam-limiting device(s) is equipped with a light localizer, answer
the questions in section 315.0, PART 300.

Answer the questions in section 316.0, PART 300.

202.4 Stationary General Purpose Radiographic (excluding mammographic
attachments, spot-film devices, and dental units)
a.

Describe the means provided to indicate when the beam axis (both
vertical and horizontal) is perpendicular to the plane of the image
receptor.

Describe the means provided to indicate each design SID.

Provide a drawing or picture of the indicator on the beam-limiting device
that shows the relationship of the field size dimensions to SID. Attach as
APPENDIX D.
Answer the questions in section 317.0, PART 300.

5
FORM FDA 3626 (1/14)

e.
f.
g.

If the PBL cassette tray is designed with continuous cassette size
sensing, give the applicable range of cassette sizes.

Provide a copy of the circuit diagram and interlock mechanism that
prevents the production of x rays when the PBL system is positioned at
SID's at which it is not designed to operate and/or when an improper
cassette is inserted. Attach as APPENDIX E.

Is the PBL adjustment of the x-ray field automatic or manual?

If the PBL adjustment of the x-ray field is accomplished automatically in
greater than 5 seconds or is manual, provide a copy of the circuit
diagram and interlock mechanism that prevents the production of x rays
until such adjustment is completed. Enclose in APPENDIX E.
Answer the questions in section 318.0, PART 300.

202.5

List the design SID's and/or range of SID's for positive beam limitation
(PBL) operation for each permanently mounted cassette holder used with
the beam-limiting device.
If the PBL cassette tray is designed with discrete cassette size sensing,
list the applicable cassette sizes.

Can the PBL x-ray field be adjusted to dimensions smaller than those of
the image receptor?

What is the size, in centimeters, of the minimum x-ray field at 100
centimeters SID?

When the PBL x-ray field is adjusted to dimensions smaller than the
image receptor, state how the beam-limiting device returns to positive
beam limitation upon a change in image receptor.

Does the PBL system have a bypass mode? If so, specify all conditions
under which the bypass mode is activated, and state whether the bypass
mode is activated under conditions other than: (1) when radiography is
conducted that does not use the cassette tray or permanently mounted
vertical cassette holder; (2) when either the beam axis or table
angulation is not within 10° of the horizontal or vertical during any part of
the exposure; or (3) during stereoscopic radiography.

If the PBL system has a bypass mode, specify the conditions under
which the system will automatically return to the PBL mode.

Describe each service switch and/or capture key override available with
the PBL system.

Provide a drawing or picture showing the location of each PBL override
switch. Enclose in APPENDIX E.

Provide circuit diagrams and description of function for each PBL bypass
and override circuit. Enclose in APPENDIX E.

Beam-Limiting Device Used with Spot Film Radiography (excluding therapy
simulators)
a. Describe how reduction of the x-ray field is accomplished when the fluoroscopic x-ray field is larger than the selected portion of the film.
6

FORM FDA 3626 (1/14)

Describe how the enlargement of the x-ray field is accomplished when
the fluoroscopic x-ray field is smaller than the selected portion of the
film.

Describe the means available to adjust the x-ray field to a size smaller
than the selected portion of the film.

What spot-film formats (i.e., geometrical size(s) and configuration(s)) are
available with this beam-limiting device(s)?

Answer the questions in section 320.0, PART 300.

What is the minimum x-ray field at the greatest SID for tube housings for
which the beam-limiting device is designed?

Specify the location of the beam-limiting device with respect to both
the patient and the image receptor when it is assembled in a
fluoroscopic system. (Does the beam-limiting device restrict the size
of the x-ray beam before or after the x-ray beam passes through the
patient?)

If means are provided for system failure override, describe: (1) each
service switch and/or capture key; (2) the label advising need for repair
in the event of system failure; and (3) the visual indication of the override
condition at the fluoroscopist position.

202.6 Beam-Limiting Device Used with Fluoroscopy
a.

Describe the means provided to adjust the x-ray field to dimensions
smaller than the entire visible area of the image receptor. If
circular collimation of any kind is provided, state the available
diameter(s).

What is the minimum x-ray field at the greatest SID for tube housings for
which the beam-limiting device is designed?

If the beam-limiting device(s) is used in nonimage-intensified
fluoroscopy, describe the means for limiting the x-ray field within the
visible area of the image receptor.

If the beam-limiting device(s) is used in image-intensified fluoroscopy,
other than radiation therapy simulation, answer the questions in section
321.0, PART 300.

For each beam-limiting device used in routine fluoroscopy give its model
designation, the applicable system(s) designation(s), a statement of
whether it is mobile or stationary, and the minimum SSD.

If any beam-limiting device/system combination is designed for special
surgical procedures, describe the provisions for maintaining an SSD of
greater than 20 centimeters.

If means are provided for system failure override, describe (1) each
service switch and/or capture key; (2) the label advising need for repair
in the event of system failure; and (3) the visual indication of the override
condition at the fluoroscopist position.

7
FORM FDA 3626 (1/14)

202.7 X-Ray Systems Designed for One SID and Image Receptor Size Combination
(e.g., chest, skull, and cephalometric)
a.

For each beam-limiting device state its model designation, the design
SID, and the image receptor size.

For each beam-limiting device describe the means for limiting and/or
centering the x-ray field.

If the beam-limiting device has a light field that defines the perimeter
of the x-ray field, answer the questions in sections 315.0 and 316.0,
PART 300.

If the x-ray field extends beyond any edge of the image receptor, answer
the questions in 317.0, PART 300.

Answer the questions in section 319.0, PART 300.

202.8 X-Ray Systems Designed for or Provided with Special Attachments for
Mammography

202.9

For each removable fixed aperture or multiple fixed aperture beamlimiting device, state the maximum design SID and image receptor size.

Provide an exact replica of all labels that show the maximum design SID
and image receptor size.

Answer the questions in section 323.0, PART 300.

Other Radiographic X-Ray Systems (e.g., extraoral dental, CT, podiatric, and
cephalometric)
a.

For each beam-limiting device describe the means for limiting and/or
centering the x-ray field.

For each removable fixed aperture, provide an exact replica of each
label or marking that shows the SID and image receptor size.

For each multiple fixed aperture, provide an exact replica of each label
or marking that shows the design SID(s) and image receptor sizes.

If the beam-limiting device has a light field that defines the perimeter
of the x-ray field, answer the questions in sections 315.0 and 316.0,
PART 300.

If the x-ray field extends beyond any edge of the image receptor, answer
the questions in 317.0, PART 300.

Answer the questions in section 324.0, PART 300.

202.10 State the maximum kVp at which each model beam-limiting device is
designed to operate.
202.11 If any filtration that is part of the beam-limiting device is variable, describe
any system of filter identification and the means of assuring the presence
of the required minimum filtration in the beam before the tube can be

8
FORM FDA 3626 (1/14)

activated. If an interlock system is used, supply or answer the
following:
a.

Provide circuit diagrams of the interlock tied to the kilovoltage
selector that is part of the beam-limiting device. Attach as APPENDIX
F.

Describe the electrical and mechanical characteristics of the interlock
system.

202.12 Answer the questions in section 301.0, PART 300.
202.13 If any model beam-limiting device contains filters, answer the questions in
section 302.0, PART 300.
202.14 If any model beam-limiting device is intended to be used on capacitor
storage x-ray systems, answer the questions in section 304.0, PART 300.

9
FORM FDA 3626 (1/14)

203.0

X-RAY CONTROLS
This section should be completed for each x-ray control listed in section 102.1
of PART 100 and any combination listed in section 102.2 of PART 100 that
contains an x-ray control as an integral part thereof.

203.1 List all uses or applications for which each model is intended, such as:
general purpose radiographic, general purpose fluoroscopic, combination
radiographic and fluoroscopic, tomographic, angiographic, podiatric, urologic,
mammographic, chest, head-neck, panoramic, intraoral (general purpose
dental), cephalometric, and computerized tomography.
203.2 Provide a replica of the warning label affixed to the control panel and specify
where the label is located with respect to the main power switch. Attach as
APPENDIX G.
203.3 If the x-ray control is used with a battery powered generator, describe the
visual means provided to indicate whether or not the battery is in a state of
charge adequate for proper operation.
203.4 Radiography (x-ray controls used for radiography, i.e., recording of images
except from image intensifiers)
a.

For each x-ray control panel, provide the following: (1) the type and
range of the markings on the technique factor indicators and the
applicable accuracy limits; (2) a drawing or picture of the preindicators of
technique factors to the operator; (3) a drawing or picture that illustrates
the proximity of any exposure switch to the preindicated technique
factors; (4) a drawing or picture of the indicator of x-ray production; and
(5) a description of the audible signal used to indicate exposure
termination. Enclose in APPENDIX G.
NOTE: “Satellite” or “remote stations” are certifiable components and
must comply with all applicable requirements pertaining to x-ray
controls.

For each accuracy specification referenced in 203.4(a), state the
applicable criteria that defines the technique factors, e.g., the begin and
end points of exposure time could be defined with respect to a certain
percentage of the voltage waveform.

Answer the questions in sections 307.0, PART 300 and as applicable,
sections 309.0, 310.0, 311.0, and 312.0, PART 300.

If two or more tubes are controlled by the same exposure switch,
describe the pre-exposure tube selection indicator on the control panel
and the provisions for indication on the diagnostic source assemblies.
Describe the control device(s) for initiating and terminating x-ray
production. Include each method by which x-ray exposure is terminated
(e.g., preset time, mAs, pulses, limit switches, or exposure to the image
receptor).

Describe the method by which the operator can terminate an exposure
or series of exposures that last longer than one-half second.

Describe the method by which termination of the exposure causes
automatic resetting of the timer to its initial setting or to zero.
10

FORM FDA 3626 (1/14)

If a “zero” or “off” position is provided, is x-ray production prevented
when the timer is set to either position?

If the x-ray control incorporates an automatic exposure control,
provide a drawing or picture of (1) the indicator for automatic exposure
control selection and (2) the visible signal that indicates when an
exposure has been terminated by the backup safety device. Enclose in
APPENDIX G.

If the exposure has been terminated by the backup safety device during
automatic exposure control operation, describe the manual resetting
procedures.
If the x-ray control incorporates an automatic exposure control, answer
the questions in sections 313.0 and 314.0, PART 300.

203.5 Fluoroscopy (x-ray controls used for fluoroscopy and for the recording of
images through an image intensifier)
a.

For each fluoroscopic exposure switch, describe the method employed
to prevent the production of x rays when the primary protective barrier is
not in position to intercept the entire useful beam.
NOTE: Therapy simulator systems with remote control are exempt from
this requirement

Describe each control device (e.g., normal fluoroscopy, cine, and test
mode) for initiating and maintaining fluoroscopic x-ray production.

Describe the means provided to preset the cumulative on-time of the
fluoroscopic tube, and state the maximum available cumulative time.

For each fluoroscopic control device, describe the method of providing a
continuing audible signal that indicates to the fluoroscopist x-ray
production beyond the completion of any preset cumulative on-time.
For each x-ray and remote control panel, provide a drawing or picture of
the indicators that allow continuous monitoring of kVp and mA during
fluoroscopy. Enclose in APPENDIX G.
For each manual and/or automatic exposure rate control mode that
initiates exposure without the permanent recording of fluoroscopic
images, state the respective maximum values of fluoroscopic entrance
exposure rates.
For each manual and/or automatic exposure rate control mode, describe
any provisions for optional high-level control and the special means
provided for activation of this option.

e.
f.

g.
h.

For each high-level control, describe the continuous audible signal that
indicates to the fluoroscopist that the high-level control is being
employed.

Describe the method by which the fluoroscopist can terminate the
recording of serial fluoroscopic images.

Answer the questions in sections 305.0, 306.0, 309.0, and 310.0, PART
300.

11
FORM FDA 3626 (1/14)

204.0

HIGH-VOLTAGE GENERATORS

This item should be completed for each high-voltage generator listed in
section 102.1 of PART 100 and any combination listed in section 102.2 of
PART 100 that contains a high-voltage generator as an integral part
thereof.
204.1 List all uses or applications for which each model is intended, such as:
general purpose radiographic, general purpose fluoroscopic, combination
radiographic and fluoroscopic, tomographic, angiographic, podiatric, urologic,
mammographic, chest, head-neck, panoramic, intraoral (general purpose
dental), cephalometric and computerized tomography.
204.2 State the generator type (e.g., single-phase half-wave, three-phase full-wave,
capacitor discharge, or field emission).
204.3 If any model high-voltage generator contains a thermionic diode valve,
answer the questions in section 308.0, PART 300.

12
FORM FDA 3626 (1/14)

205.0

SPOT-FILM DEVICES AND IMAGE INTENSIFIERS
This section should be completed for each spot-film device and image
intensifier listed in section 102.1 of PART 100 and any combination listed in
section 102.2 of PART 100 that contains such components as an integral part
thereof.

205.1 If the reported system is a mobile fluoroscope, is it image intensified?
205.2

For each model spot-film device and image intensifier, describe the means to
prevent the fluoroscopic tube from producing x radiation whenever the
primary protective barrier is not in position to intercept the entire useful beam.
If there is an interlock, describe its electrical and mechanical characteristics
and provide circuit diagrams. Attach as APPENDIX H.

205.3

If the spot-film device or image intensifier permits technique factor adjustment,
answer the questions in section 203.0, PART 200 - COMPONENT
DESCRIPTION.

205.4

For each spot-film device answer the questions in sections 306.0, PART 300.

205.5

For each image intensifier answer the questions in sections 306.0 and 308.0,
PART 300.

13
FORM FDA 3626 (1/14)

206.0

TABLE, CASSETTE HOLDERS*, FILM CHANGERS AND CRADLES
This section should be completed for each table, cassette holder, film changer
and/or cradle listed in section 102.1 of PART 100 and any combination listed
in section 102.2 of PART 100 that contains such components as an integral
part thereof.

206.1 If any of the subject components (1) allows for operator adjustment of
technique factors or (2) provides limit switches that automatically preempt the
preset exposure time of the master control panel, answer the questions in
section 203.0, PART 200 - COMPONENT DESCRIPTION.
206.2 If any film changer is built into a stationary radiographic table, explain how
positive beam limitation is accomplished for serial radiography.
206.3 For each model film changer, explain the provision(s) enabling the operator to
terminate an exposure or series of exposures that last longer than one-half
second.
206.4 For each model table x-ray table, identify its appropriate characteristics from
the following: stationary table, movable table, stationary tabletop, movable
tabletop, table designed for therapy simulation, table designed for computed
tomography, cantilevered table, weight-bearing radiolucent attachment for
surgical tables, other (describe).
206.5 For each table intended for use on a general purpose x-ray system, cite the
specific paragraph(s) in your instructions to assemblers that lists
compatible tube stands and/or other equipment necessary for indication
(as required under 21 CFR 1020.31(e)(1)(i), (g)(2), and 1020.32(b)(1)(ii),
(b)(2)(iii)) of:
a.

the perpendicularity of the beam axis to the image receptor, and

the SID.

206.6 If the vertical cassette holder is equipped with cassette size sensors, state the
intended image receptor sizes.
206.7 Answer the questions in section 303.0, PART 300.

*Applicable only to cassette holders that are intended for permanent vertical
mounting and/or contain a front panel.
14
FORM FDA 3626 (1/14)

207.0

CEPHALOMETRIC DEVICES
This section should be completed for each cephalometric device listed in
section 102.1 of PART 100.

207.1 For each model cephalometric device that includes a beam-limiting device as
an integral design feature, answer the applicable questions in section 202.0,
PART 200 - COMPONENT DESCRIPTION.
207.2 For each model cephalometric device that includes a cassette holder with a
front panel as an integral design feature, answer the questions in section
303.0, PART 300.

15
FORM FDA 3626 (1/14)

208.0

IMAGE RECEPTOR SUPPORT DEVICES FOR MAMMOGRAPHIC X-RAY SYSTEMS
This section should be completed for each image receptor support device
listed in section 102.1 of PART 100.

208.1 For each model image receptor support device that includes a cassette holder
with a front panel as an integral part, answer the questions in section 303.0,
PART 300.
208.2 Answer the questions in section 325.0, PART 300.

16
FORM FDA 3626 (1/14)

PART 300 - QUALITY CONTROL TESTING
301.0 LEAKAGE RADIATION FROM THE DIAGNOSTIC SOURCE ASSEMBLY
301.1 Requirement
The leakage radiation from the diagnostic source assembly measured at a
distance of 1 meter in any direction from the source shall not exceed 100
milliroentgens in 1 hour when the x-ray tube is operated at its leakage
technique factors. Compliance shall be determined by measurements
averaged over an area of 100 square centimeters with no linear dimension
greater than 20 centimeters (1020.30(k)).
301.2 Applicability
This requirement is applicable to the diagnostic source assembly (tube
housing assembly combined with a beam-limiting device). Similar models of a
single component type may be grouped for presentation of test results
applicable to this requirement when the technical basis for this grouping is
clearly stated in the description of prototype testing (see 301.4(a)).
301.3 Critical Parameters and “Worst Case” Conditions
a.

The test results must include date representative of each compatible
combination of tube housing assembly and beam-limiting device.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

To assure the use of maximum rated peak tube potential and continuous
tube current, the test method(s) must provide the procedure for periodic
calibration of technique factors.

For any test using a scan of the diagnostic source assembly, the rate of
scan specified in the test method(s) must account for the response time
of the radiation instrumentation.

301.4 Prototype Testing
a.

Describe the direct test method (i.e., one that actually measures x
radiation) employed in testing and measuring each model with respect to
this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

17
FORM FDA 3626 (1/14)

301.5 Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually measure x
radiation, explain why it is an accurate indication of compliance with the
requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Attach as APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 301.5, give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 301.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

301.6 Assembler Testing
a.-i. If test instructions are provided to the assembler, answer the questions
in 301.5 with respect to assembler testing. Note: The information
requested in 301.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

18
FORM FDA 3626 (1/14)

302.0

BEAM QUALITY

302.1

Requirement
The half-value layer of the useful beam for a given x-ray tube potential shall
not be less than the values shown in Table I of the diagnostic x-ray standard
(see 1020.30(m)).

302.2

Applicability
This requirement is applicable to the tube housing assembly or the
diagnostic source assembly if the beam-limiting device contains filtration.
Similar models of a single component type may be grouped for presentation
of test results applicable to this requirement when the technical basis for
this grouping is clearly stated in the description of prototype testing (see
302.4(a)).

302.3 Critical Parameters and “Worst Case” Conditions
a.

The test results must include data representative of each compatible
combination of tube housing assembly and beam-limiting device.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

Since the peak tube potential has a critical effect on determining the halfvalue layer, the test method(s) must provide the procedure for periodic
calibration of tube potential.

To minimize the sources of scatter radiation, the x-ray field specified in
the test method(s) must be just large enough to cover the sensitive
volume of the detector.

302.4 Prototype Testing
a.

Describe the direct test method (i.e., one that actually measures x
radiation) employed in testing and measuring each model with respect to
this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

302.5 Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually measure x
radiation, explain why it is an accurate indication of compliance with this
requirement.

19
FORM FDA 3626 (1/14)

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 302.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 302.5(a) provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provided a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

302.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 302.5 with respect to assembler testing. Note: The information
requested in 302.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

20
FORM FDA 3626 (1/14)

303.0

ALUMINUM EQUIVALENCE

303.1

Requirement
The aluminum equivalent of the front panels of cassette holders and film
changers, tabletops, and cradles that are used between the patient and image
receptor shall not exceed the limits indicated in Table II of the diagnostic x-ray
standard (see 1020.30(n)).

303.2

Applicability
The requirement is applicable to cassette holders, film changers, tables and
cradles. Similar models of a single component type may be grouped for
presentation of test results applicable to this requirement when the technical
basis for this grouping is clearly stated in the description of prototype testing
(see 303.4(a)).

303.3 Critical Parameters and “Worst Case” Conditions
a.

As a result of inherent inaccuracies of the test method and
instrumentation, rejection limits for any test must be sufficiently
restrictive to assure compliance with the standard.

Since the peak tube potential has a critical effect on determining the
aluminum equivalent, the test method(s) must provide the procedure for
periodic calibration of tube potential.

Since compliance will be measured at 100 kVp and 2.7 millimeters of
aluminum half-value layer, test data resulting from other conditions must
be extrapolated to the value at the specified conditions.

303.4 Prototype Testing
a.

Describe the direct test method (i.e., one that actually measures x
radiation) employed in testing and measuring each model with respect to
this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

303.5 Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually measure x
radiation, explain why it is an accurate indication of compliance with this
requirement.

Submit the technical data that supports the use of the test in b.

21
FORM FDA 3626 (1/14)

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 303.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 303.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

303.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 303.5 with respect to assembler testing. Note: The information
requested in 303.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

22
FORM FDA 3626 (1/14)

304.0

STANDBY RADIATION FROM CAPACITOR ENERGY STORAGE EQUIPMENT

304.1

Requirement
Radiation emitted from the x-ray tube when the exposure switch or timer is
not activated shall not exceed a rate of 2 milliroentgens per hour at 5
centimeters from any accessible surface of the diagnostic source assembly,
with the beam-limiting device fully open (see 1020.31(k)).

304.2

Applicability
The requirement is applicable to the diagnostic source assembly of capacitor
energy storage equipment. Similar models of a single component type may be
grouped for presentation of test results applicable to this requirement when
the technical basis for this grouping is clearly stated in the description of
prototype testing (see 304.4(a)).

304.3 Critical Parameters and “Worst Case” Conditions
a.

The test results must include data representative of each compatible
combination of tube housing assembly and beam-limiting device.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

To test for the maximum standby radiation, the beam-limiting device
must be fully open and the highest available peak tube potential must be
used. These conditions must be specified in the test method(s).

For any test using a scan of the diagnostic source assembly, the rate of
scan specified in the test method(s) must take into account the response
time of the radiation instrument.

304.4 Prototype Testing
a.

Describe the direct test method (i.e., one that actually measures x
radiation) employed in testing and measuring each model with respect to
this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

304.5 Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually measure x
radiation, explain why it is an accurate indication of compliance with this
requirement.
23

FORM FDA 3626 (1/14)

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 304.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 304.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

304.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 304.5 with respect to assembler testing. Note: The information
requested in 304.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

24
FORM FDA 3626 (1/14)

305.0

FLUOROSCOPIC ENTRANCE EXPOSURE RATE

305.1

Requirement
a.

305.2

Fluoroscopic equipment that is provided with automatic exposure rate
control shall not be operable at any combination of tube potential and
current that will result in an exposure rate in excess of 10 roentgens per
minute at the point where the center of the useful beam enters the
patient, except:
(1)

during recording of fluoroscopic images, or

(2)

when an optional high-level control is provided. When so
provided, the equipment shall not be operable at any combination
of tube potential and current that will result in an exposure rate in
excess of 5 roentgens per minute at the point where the center of
the useful beam enters the patient unless the high-level control is
activated.

Fluoroscopic equipment that is not provided with automatic exposure
rate control shall not be operable at any combination of tube potential
and current that will result in an exposure rate in excess of 5 roentgens
per minute at the point where the center of the useful beam enters the
patient, except:
(1)

during recording of fluoroscopic images, or

(2)

when an optional high-level control is activated (see 1020.32(d)).

Applicability
The requirement is applicable to fluoroscopic and automatic exposure
rate x-ray control. Similar models of a single component type may be
grouped for presentation of test results applicable to this requirement when
the technical basis for this grouping is clearly stated in the description of
prototype testing (see 305.4(a)).

305.3 Critical Parameters and “Worst Case” Conditions
a.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

To test for the maximum entrance exposure rate, the beam-limiting
device must be fully open. This condition must be specified in the test
method(s).

For equipment without automatic exposure rate control, the test results
must include data for “worst case” combinations of peak tube potentials
and tube currents (e.g., maximum kVp and mA).

For equipment with automatic exposure rate control, the technique
factors specified in the test method(s) must be driven to the maximum
design limits for this test.

For automatic exposure rate control equipment using direct viewing
optics, the test must be performed with suppressed ambient light
conditions.
25

FORM FDA 3626 (1/14)

305.4 Prototype Testing

305.5

Describe the direct test method (i.e., one that actually measures x
radiation) employed in testing and measuring each model with respect to
this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually measure x
radiation, explain why it is an accurate indication of compliance with this
requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 305.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 305.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

304.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 305.5 with respect to assembler testing. Note: The information
requested in 305.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

26
FORM FDA 3626 (1/14)

306.0

PRIMARY PROTECTIVE BARRIER TRANSMISSION

306.1

Requirement
The exposure rate due to transmission through the barrier with the attenuation
block in the useful beam combined with radiation from the image intensifier, if
provided, shall not exceed 2 milliroentgens per hour at 10 centimeters from
any accessible surface of the fluoroscopic imaging assembly beyond the
plane of the image receptor for each roentgen per minute of entrance
exposure rate (see 1020.32(a)(i)).

306.2 Applicability
The requirement is applicable to fluoroscopic imaging assemblies or the
following component parts thereof: spot-film device; image intensifier; and
fluoroscopic screen assembly. Similar models of a single component type
may be grouped for presentation of test results applicable to this requirement
when the technical basis for this grouping is clearly stated in the description of
prototype testing (see 306.4(a)).
306.3 Critical Parameters and “Worst Case” Conditions
a.

The test results must include data representative of each compatible
combination of components that comprise the fluoroscopic imaging
assembly.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.
For any test using a scan of the fluoroscopic imaging assembly, the rate
of scan specified in the test method(s) must take into account the
response time of the radiation instrument.

c.
d.

To test for the transmission of radiation through the primary protective
barrier, the beam-limiting device must be fully open and the highest
available peak tube potential must be used. These conditions must be
specified in the test method(s).

If an oblique fluoroscopic capability is provided, the radiation transmitted
through the primary protective barrier must be measured at the
maximum oblique fluoroscopic angles.

If the fluoroscopic beam-limiting device is equipped with an override
capability, the radiation transmitted through the primary protective barrier
must be measured at the largest x-ray field setting.

306.4 Prototype Testing
a.

Describe the direct test method (i.e., one that actually measures x
radiation) employed in testing and measuring each model with respect to
this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.
27

FORM FDA 3626 (1/14)

306.5

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually measure x
radiation, explain why it is an accurate indication of compliance with this
requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 306.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 306.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

306.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 306.5 with respect to assembler testing. Note: The information
requested in 306.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

28
FORM FDA 3626 (1/14)

307.0

REPRODUCIBILITY AND LINEARITY

307.1

Requirement
When the x-ray unit is operated on an adequate power supply as specified
by the manufacturer; (1) the estimated coefficient of variation of radiation
exposure shall not be greater than 0.05 for any specific combination
of technique factors, and (2) the average ratios of exposure to the
indicated tube current exposure time product (mAs) obtained at any two
consecutive tube current settings shall not differ by more than 0.10 times
their sum, or
X1 - X2
X1 + X2

< 0.10

where X1 and X2 are the average mR/mAs values obtained at each of two
consecutive tube current settings.
(see 1020.31(b) and (c)).
307.2 Applicability
The requirement is applicable to radiographic x-ray controls and high-voltage
generators. Similar models of a single component type may be grouped for
presentation of test results applicable to this requirement when the technical
basis for this grouping is clearly stated in the description of prototype testing
(see 307.4(a)).
307.3 Critical Parameters and “Worst Case” Conditions
a.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

To assure compliance with the reproducibility and linearity requirements,
the test results must include data for “worst case” combinations of
technique factors and supply line conditions (e.g., low kVp, high mA, lowline voltage, and highest allowed line-voltage regulation).

To determine compliance, variable controls for technique factors shall be
adjusted to alternate settings and rest to the test setting between
measurements.
307.4 Prototype Testing
a.

Describe the direct test method (i.e., one that actually measures x
radiation) employed in testing and measuring each model with respect to
this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.
29

FORM FDA 3626 (1/14)

307.5

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually measure x
radiation, explain why it is an accurate indication of compliance with this
requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 407.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 407.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

307.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 307.5 with respect to assembler testing. Note: The information
requested in 307.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

30
FORM FDA 3626 (1/14)

308.0

RADIATION FROM COMPONENTS OTHER THAN THE DIAGNOSTIC
SOURCE ASSEMBLY

308.1

Requirement
The radiation emitted by a component other than the diagnostic source
assembly shall not exceed 2 milliroentgens in 1 hour at 5 centimeters from
any accessible surface of the component when it is operated in an assembled
x-ray system under an conditions for which it was designed (see 1020.30(1)).

308.2 Applicability
The requirement is applicable to x-ray controls, high-voltage generators
that contain thermionic diode valves (valve tubes), and image intensifiers.
Similar models of a single component type may be grouped for presentation
of test results applicable to this requirement when the technical basis
for this grouping is clearly stated in the description of prototype testing
(see 308.4(a)).
308.3 Critical Parameters and “Worst Case” Conditions
a.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

For any test using a scan of the subject components, the rate of scan
specified in the test method(s) must take into account the response time
of the radiation instrument.

To test for the maximum leakage radiation from the subject component,
the highest available peak tube potential must be used. This condition
must be specified in test method(s).

308.4 Prototype Testing

308.5

Describe the direct test method (i.e., one that actually measures x
radiation) employed in testing and measuring each model with respect to
this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually measure x
radiation, explain why it is an accurate indication of compliance with this
requirement.

Submit the technical data that supports the use of the test in b.
31

FORM FDA 3626 (1/14)

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 308.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 308.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

308.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 308.5 with respect to assembler testing. Note: The information
requested in 308.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

32
FORM FDA 3626 (1/14)

309.0 PEAK TUBE POTENTIAL
309.1

Requirement
The manufacturer shall state the maximum deviation of the peak tube
potential from its preindicated value during an exposure, when the equipment
if connected to an adequate power supply as specified by the manufacturer.
The deviation of the peak tube potential shall not exceed the limits given
(see 1020.31(a)(4) and 1020.32(e)).

309.2 Applicability
The requirement is applicable to fluoroscopic and radiographic x-ray controls
and high-voltage generators. Similar models of a single component type may
be grouped for presentation of test results applicable to this requirement when
the technical basis for this grouping is clearly stated in the description of
prototype testing (see 309.4(a)).
309.3 Critical Parameters and “Worst Case” Conditions
a.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

To assure compliance with the maximum deviation statements provided
to the user, the test results must include data for “worst case”
combinations of technique factors and supply line conditions (e.g.,
highest kW, low line voltage, and highest allowed line-voltage
regulation).

309.4 Prototype Testing

309.5

Describe the direct test method (i.e., a direct electrical measurement
such as a voltage divider, oscilloscope or voltmeter) employed in testing
and measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance is not a direct electrical
measurement such as a voltage divider, oscilloscope or voltmeter,
explain why it is an accurate indication of compliance with this
requirement.

Submit the technical data that supports the use of the test in b.

33
FORM FDA 3626 (1/14)

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 309.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 309.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

309.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 309.5 with respect to assembler testing. Note: The information
requested in 309.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

34
FORM FDA 3626 (1/14)

310.0 TUBE CURRENT
310.1

Requirement
The manufacturer shall state the maximum deviation of the tube current from
its preindicated value during an exposure, when the equipment is connected
to an adequate power supply as specified by the manufacturer. The deviation
of the tube current shall not exceed the limits given (see 1020.31(a)(4) and
1020.32(e)).

310.2 Applicability
The requirement is applicable to fluoroscopic and radiographic x-ray controls
and high-voltage generators. Similar models of a single component type may
be grouped for presentation of test results applicable to this requirement when
the technical basis for this grouping is clearly stated in the description of
prototype testing (see 310.4(a)).
310.3 Critical Parameters and “Worst Case” Conditions
a.
b.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.
To assure compliance with the maximum deviation statements provided
to the user, the test results must include data for “worst case”
combinations of technique factors and supply line conditions (e.g.,
highest kW, low line voltage, and highest allowed line-voltage
regulation).

310.4 Prototype Testing

310.5

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.
35

FORM FDA 3626 (1/14)

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 310.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 310.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

310.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 310.5 with respect to assembler testing. Note: The information
requested in 310.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

36
FORM FDA 3626 (1/14)

311.0 TUBE CURRENT-EXPOSURE TIME PRODUCT
311.1

Requirement
The manufacturer shall state the maximum deviation of the tube current
exposure time product (mAs) from its preindicated value during and exposure,
when the equipment is connected to an adequate power supply as specified
by the manufacturer. The deviation of the tube current exposure time product
shall not exceed the limits given (see 1020.31(a)(4)).

311.2 Applicability
The requirement is applicable to radiographic x-ray controls and high-voltage
generators that have mAs settings. Similar models of a single component type
may be grouped for presentation of test results applicable to this requirement
when the technical basis for this grouping is clearly stated in the description of
prototype testing (see 311.4(a)).
311.3 Critical Parameters and “Worst Case” Conditions
a.
b.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.
To assure compliance with the maximum deviation statements provided
to the user, the test results must include data for “worst case”
combinations of technique factors and supply line conditions (e.g.,
highest kW, low line voltage, and highest allowed line-voltage
regulation).

311.4 Prototype Testing

311.5

Describe the direct test method (i.e., a direct electrical measurement
such as a milliampere - second meter) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance is not a direct electrical
measurement such as a milliampere - second meter, explain why it is an
accurate indication of compliance with this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.
37

FORM FDA 3626 (1/14)

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 311.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 311.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

311.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 311.5 with respect to assembler testing. Note: The information
requested in 311.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

38
FORM FDA 3626 (1/14)

312.0 EXPOSURE TIME
312.1

Requirement
The manufacturer shall state the maximum deviation of the exposure time
from its preindicated value during an exposure, when the equipment is
connected to an adequate power supply as specified by the manufacturer.
The deviation of exposure time shall not exceed the limits given (see
1020.31(a)(4)).

312.2 Applicability
The requirement is applicable to radiographic x-ray controls and high-voltage
generators. Similar models of a single component type may be grouped for
presentation of test results applicable to this requirement when the technical
basis for this grouping is clearly stated in the description of prototype testing
(see 312.4(a)).
312.3 Critical Parameters and “Worst Case” Conditions
a.
b.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.
To assure compliance with the maximum deviation statements provided
to the user, the test results must include data for “worst case”
combinations of technique factors and supply line conditions (e.g.,
highest kW, low-line voltage, and highest allowed line-voltage
regulation).

312.4 Prototype Testing

312.5

Describe the direct test method (i.e., a direct radiation or electrical
measurement such as a voltage divider, oscilloscope) employed in
testing and measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance is not a direct radiation or
electrical measurement such as a voltage divider or oscilloscope, explain
why it is an accurate indication of compliance with this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.
39

FORM FDA 3626 (1/14)

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 312.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 312.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

312.6 Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 312.5 with respect to assembler testing. Note: The information
requested in 312.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

40
FORM FDA 3626 (1/14)

313.0 AUTOMATIC EXPOSURE CONTROL LIMITS
313.1

Requirement
Either the product of peak x-ray tube potential, current, and exposure time
shall be limited to not more than 60 kWs per exposure or the product of x-ray
tube current and exposure time shall be limited to not more than 600 mAs per
exposure except when the x-ray tube potential is less than 50 kVp in which
case the product of x-ray tube current and exposure time shall be limited to
not more than 2000 mAs per exposure (see 1020.31(a)(3)(iii)).

313.2 Applicability
The requirement is applicable to radiographic x-ray controls and highvoltage generators used in systems with automatic exposure controls.
Similar models of a single component type may be grouped for presentation
of test results applicable to this requirement when the technical basis for
this grouping is clearly stated in the description of prototype testing (see
313.4(a)).
313.3 Critical Parameters and “Worst Case” Conditions
a.
b.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.
To assure compliance with 60 kWs, 600 mAs, or 2000 mAs limits
applicable to this system, the test results must include data for various
combinations of technique factors.

313.4 Prototype Testing
a.

b.
c.
d.

313.5

Describe the direct test method (i.e., a direct electrical measurement
such as a voltage divider, oscilloscope or voltmeter or millamperesecond meter) employed in testing and measuring each model with
respect to this requirement.
Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).
Provide sample raw test data.
If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.
b.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.
If any test used to monitor compliance is not a direct electrical
measurement such as a voltage divider, oscilloscope, voltmeter or
milliampere - second meter, explain why it is an accurate indication of
compliance with this requirement.
Submit the technical data that supports the use of the test in b.

41
FORM FDA 3626 (1/14)

313.6

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 313.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 313.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 313.5 with respect to assembler testing. Note: The information
requested in 313.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

42
FORM FDA 3626 (1/14)

314.0 AUTOMATIC EXPOSURE CONTROL MINIMMUM EXPOSURE TIME
314.1

Requirement
When the x-ray tube potential is equal to or greater than 50 kVp, the minimum
exposure time of field emission equipment rated for pulsed operation shall be
equal to or less than a time interval equivalent to two pulses, and the
minimum exposure time for all other equipment shall be equal to or less than
1/60 second or a time interval required to deliver 5 mAs, whichever is greater
(see 1020.31(a)(3)(ii)).

314.2 Applicability
The requirement is applicable to radiographic x-ray controls and highvoltage generators used in systems with automatic exposure controls.
Similar models of a single component type may be grouped for presentation
of test results applicable to this requirement when the technical basis for
this grouping is clearly stated in the description of prototype testing (see
314.4(a)).
314.3 Critical Parameters and “Worst Case” Conditions
a.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

314.4 Prototype Testing

314.5

Describe the direct test method (i.e., a direct radiation or electrical
measurement ) employed in testing and measuring each model with
respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance is not a direct radiation or
electrical measurement, explain why it is an accurate indication of
compliance with this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).
43

FORM FDA 3626 (1/14)

314.6

For each test method in 314.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 314.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 314.5 with respect to assembler testing. Note: The information
requested in 314.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

44
FORM FDA 3626 (1/14)

315.0 ILLIMINANCE OF LIGHT LOCALIZERS
315.1

Requirement
When a light localizer is used to define the perimeter of the x-ray field,
it shall provide an average illumination of not less than 160 lux (15
footcandles) at 100 centimeters or at the maximum SID whichever is less.
The average illumination shall be based upon measurements made in the
approximate center of each quadrant of the light field (see 1020.31(d)(2)(ii)
and (f)(4)(i)).

315.2 Applicability
The requirement is applicable to any beam-limiting devices in a general
purpose or other radiographic system that uses a light localizer to define the
perimeter of the x-ray field. Similar models of a single component type may be
grouped for presentation of test results applicable to this requirement when
the technical basis for this grouping is clearly stated in the description of
prototype testing (see 315.4(a)).
315.3 Critical Parameters and “Worst Case” Conditions
a.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

315.4 Prototype Testing

315.5

Describe the direct test method (i.e., one that actually measures
illumination) employed in testing each model with respect to this
requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually measure
illumination, explain why it is an accurate indication of compliance with
this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).
45

FORM FDA 3626 (1/14)

315.6

For each test method in 315.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 315.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 315.5 with respect to assembler testing. Note: The information
requested in 315.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

46
FORM FDA 3626 (1/14)

316.0 ALIGNMENT OF VISUALLY DEFINED X-RAY FIELDS AND CONTRAST OF
LIGHT DEFINED X-RAY FIELDS
316.1 Requirement
a.

Visual fields (including light fields): Means shall be provided for visually
defining the perimeter of the x-ray field for all general purpose x-ray
systems. The total misalignment of the edges of the visually defined field
with the respective edges of the x-ray field along either the length or
width of the visually defined field shall not exceed 2 percent of the
distance from the source to the center of the visually defined field when
the surface upon which it appears is perpendicular to the axis of the
x-ray beam (see 1020.31(d)(2)(i)).

Light fields: The edge of the light field at 100 centimeters or at the
maximum SID, whichever is less, shall have a contrast ratio, corrected
for ambient lighting, of not less than 4 in the case of beam-limiting
devices designed for use on stationary general purpose equipment, and
a contrast ratio of not less than 3 in the case of beam-limiting devices
designed for use on mobile general purpose and other radiographic
equipment (see 1020.31(d)(2)(iii) and (f)(4)(i).

316.2 Applicability
The requirement is applicable to any beam-limiting device in a general
purpose or other radiographic system that uses a light localizer to define the
perimeter of the x-ray field. Similar models of a single component type may be
grouped for presentation of test results applicable to this requirement when
the technical basis for this grouping is clearly stated in the description of
prototype testing (see 316.4(a)).
316.3 Critical Parameters and “Worst Case” Conditions
a.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

To assure compliance with the requirement for visually defining the
perimeter of the x-ray field, the test results must include data for the
range of SID's and image receptor sizes.

316.4 Prototype Testing
a.

Describe the direct test method (i.e., one that actually measures
alignment and the contrast ratio) employed in testing and measuring
each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

47
FORM FDA 3626 (1/14)

316.5

316.6

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually measure the
alignment and contrast ratio, explain why it is an accurate indication of
compliance with this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 316.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 316.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 316.5 with respect to assembler testing. Note: The information
requested in 316.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

48
FORM FDA 3626 (1/14)

317.0 ALIGNMENT OF THE CENTER OF THE RADIPGRAPHIC X-RAY FIELD WITH
THE CENTER OF THE IMAGE RECEPTOR
317.1 Requirement
a.

For stationary general purpose x-ray systems, the center of the x-ray
field shall align with the center of the image receptor to within 2 percent
of the SID (see 1020.31(e)(1)(i)).

For other x-ray systems, the center of the x-ray field shall align
with the center of the image receptor to within 2 percent of the SID
unless means are provided to size and align the x-ray field such
that the x-ray field at the plane of the image receptor does not
extend beyond any edge of the image receptor (see 1020.31(f)(2)
and (4)).

317.2 Applicability
This requirement is applicable to beam-limiting device used in radiographic xray systems other than (a) mobile x-ray systems; (b) systems for spot filming;
(c) systems intended solely for intraoral image receptors; and (d) systems
used solely for mammography. Similar models of a single component type
may be grouped for presentation of test results applicable to this requirement
when the technical basis for this grouping is clearly stated in the description of
prototype testing (see 317.4(a)).
317.3 Critical Parameters and “Worst Case” Conditions
a.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

To assure compliance with the centering requirement, the test results
must include data for various combinations of SIDs and image receptor
sizes.

317.4 Prototype Testing

317.5

Describe the direct test method (i.e., one that actually compares the
alignment of the parameters in the requirement) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

49
FORM FDA 3626 (1/14)

317.6

If any test used to monitor compliance does not actually compare the
alignment of the parameters in the requirement, explain why it is an
accurate indication of compliance with this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 317.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 317.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 317.5 with respect to assembler testing. Note: The information
requested in 317.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

50
FORM FDA 3626 (1/14)

318.0 RADIOGRAPHIC X-RAY FIELD SIZE AND IMAGE RECEPTOR SIZE
318.1 Requirement
a.

General purpose stationary x-ray systems: The beam-limiting device
shall numerically indicate the field size in the plane of the image
receptor to which it is adjusted. Indication of field size dimensions and
SID's shall be specified in inches and/or centimeters and shall be such
that aperture adjustments result in x-ray field dimensions in the plane of
the image receptor that correspond to those indicated by the beamlimiting device to within 2 percent of the SID when the beam axis is
perpendicular to the plane of the image receptor (see 1020.31(e)(1)(ii)
and (iii)).

Systems with positive beam limitation: The x-ray field size in the plane of
the image receptor, whether automatically or manually adjusted, shall be
such that neither the length nor the width of the x-ray field differs from
that of the image receptor by greater than 3 percent of the SID and that
the sum of the length and width differences without regard to sign be no
greater than 4 percent of the SID when the equipment indicates that the
beam axis is perpendicular to the plane of the image receptor (see
1020.31(e)(2)(ii)).

318.2 Applicability
This requirement is applicable to beam-limiting device and permanently
mounted cassette holders that are used in stationary general purpose
systems. Similar models of a single component type may be grouped for
presentation of test results applicable to this requirement when the
technical basis for this grouping is clearly stated in the description of
prototype testing (see 318.4(a)).
318.3 Critical Parameters and “Worst Case” Conditions

318.4

The test results must include data representative of each compatible
combination of tube housing assemblies and beam-limiting devices.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

To assure compliance with the positive beam limitation requirements, the
test results must include date for (1) the horizontal and vertical ranges of
SID's and image receptor sizes and (2) the +10° range of angulation
relative to a line perpendicular to the plane of the image receptor.

Since the SID is used for calculating the compliance values of this
requirement, the accuracy of the SID measurement must be verified.

Prototype Testing
a.

Describe the direct test method (i.e., one that actually compares the
alignment of the parameters in the requirement) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).
51

FORM FDA 3626 (1/14)

318.5

318.6

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually compare the
alignment of the parameters in the requirement, explain why it is an
accurate indication of compliance with this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 318.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 318.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 318.5 with respect to assembler testing. Note: The information
requested in 318.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

52
FORM FDA 3626 (1/14)

319.0 X-RAY FIELD SIZE DETERMINATION FOR FIXED SID/IMAGE RECEPTOR
SIZE RADIOGRAPHIC EQUIPMENT
319.1

Requirement
Radiographic equipment designed for only one image receptor size at a
fixed SID shall be provided with means to limit the field at the plane of the
image receptor to dimensions no greater than those of the image receptor,
or shall be provided with means to both size and align the x-ray field such
that the x-ray field at the plane of the image receptor does not extend beyond
any edge of the image receptor (see 1020.31(f)(2)).

319.2 Applicability
The requirement is applicable to beam-limiting devices. Similar models of a
single component type may be grouped for presentation of test results
applicable to this requirement when the technical basis for this grouping is
clearly stated in the description of prototype testing (see 319.4(a)).
319.3 Critical Parameters and “Worst Case” Conditions
a.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

319.4 Prototype Testing

319.5

Describe the direct test method (i.e., one that actually compares the
alignment of the parameters in the requirement) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.

If any test used to monitor compliance does not actually compare the
alignment of the parameters in the requirement, explain why it is an
accurate indication of compliance with this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

53
FORM FDA 3626 (1/14)

318.6

For each test method in 319.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 319.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 319.5 with respect to assembler testing. Note: The information
requested in 319.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

54
FORM FDA 3626 (1/14)

320.0 ALIGNMENT OF X-RAY FIELD AND SPOT-FILM CASSETTE
320.1

Requirement
a.

The total misalignment of the edges of the x-ray field with the
respective edges of the selected portion of the image receptor along
the length or width dimensions of the x-ray field in the plane of the
image receptor, when adjusted for full coverage of the selected
portion of the image receptor, shall not exceed 3 percent of the SID.
The sum without regard to sign of the misalignment along any two
orthogonal dimensions shall not exceed 4 percent of the SID (see
1020.31(g)(2)).

The center of the x-ray field in the plane of the film shall be aligned with
the center of the selected portion of the film to within 2 percent of the SID
(see 1020.31(g)(4)).

320.2 Applicability
This requirement is applicable to any beam-limiting devices and spot-film
devices. Similar models of a single component type may be grouped for
presentation of test results applicable to this requirement when the technical
basis for this grouping is clearly stated in the description of prototype testing
(see 320.4(a)).
320.3 Critical Parameters and “Worst Case” Conditions

320.4

320.5

The test results must include data representative of each compatible
combination of beam-limiting devices and spot-film devices.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

To assure compliance with the spot-film x-ray field limitation requirement,
the test results must include data for the range of SID's and applicable
spot-film formats for each image receptor size.

Prototype Testing
a.

Describe the direct test method (i.e., one that actually compares the
alignment of the parameters in the requirement) employed in testing
and measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturers and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.
55

FORM FDA 3626 (1/14)

320.6

If any test used to monitor compliance does not actually compare the
alignment of the parameters in the requirement, explain why it is an
accurate indication of compliance with this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturers and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 320.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 320.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 320.5 with respect to assembler testing. Note: The information
requested in 320.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

56
FORM FDA 3626 (1/14)

321.0 ALIGNMENT OF EDGES OF THE X-RAY FIELD WITH THE EDGES OF THE
FLUOROSCOPIC IMAGE RECEPTOR
321.1

Requirement
For nonimage intensified fluoroscopy, the x-ray field shall not extend
beyond the visible are of the image receptor. For image intensified
fluoroscopy:
a. The total misalignment of the edges of the x-ray field with the
respective edges of the visible area of the image receptor along any
dimension of the visually defined field in the plane of the image receptor
shall not exceed 3 percent of the SID. The sum, without regard to
sign, of the misalignment along any two orthogonal dimensions
intersecting at the center of the visible area of the image receptor
shall not exceed 4 percent of the SID.
b.

For rectangular x-ray fields used with circular image receptors, the error
in alignment shall be determined along the length and width dimensions
of the x-ray field that pass through the center of the visible area of the
image receptor (see 1020.32(b)(2)).

321.2 Applicability
This requirement is applicable to any beam-limiting devices and image
intensifiers. Similar models of a single component type may be grouped for
presentation of test results applicable to this requirement when the technical
basis for this grouping is clearly stated in the description of prototype testing
(see 321.4(a)).
321.3 Critical Parameters and “Worst Case” Conditions

321.4

The test results must include data representative of each compatible
combination of beam-limiting devices and image intensifiers.

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

To assure compliance with the fluoroscopic x-ray field limitation
requirement, the test results must include data for the range of SID's and
available magnification modes that result in different visual areas on the
input phosphor of the image intensifier.

Prototype Testing
a.

Describe the direct test method (i.e., one that actually compares the
alignment of the parameters in the requirement) employed in testing
and measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.
57

FORM FDA 3626 (1/14)

321.5

Production Testing
a.

321.6

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.
If any test used to monitor compliance does not actually measure and
compare the alignment of the parameters in the requirement, explain
why it is an accurate indication of compliance with this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 321.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 321.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 321.5 with respect to assembler testing. Note: The information
requested in 321.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

58
FORM FDA 3626 (1/14)

322.0 X-RAY FIELD SIZE DETERMINATION FOR DENTAL EQUIPMENT USING
INTRAORAL IMAGE RECEPTORS
322.1

Requirement
Radiographic equipment designed for use with an intraoral image receptor
shall be provided with means to limit the x-ray beam such that:
a.

If the minimum source-to-skin distance (SSD) is 18 centimeters or more,
the x-ray field at the minimum SSD shall be containable in a circle having
a diameter of no more than 7 centimeters; or

If the minimum SSD is less than 18 centimeters, the x-ray field at the
minimum SSD shall be containable in a circle having a diameter of no
more than 6 centimeters (see 1020.31(f)(1)(i) and (ii)).

322.2 Applicability
This requirement is applicable to any beam-limiting devices. Similar models of
a single component type may be grouped for presentation of test results
applicable to this requirement when the technical basis for this grouping is
clearly stated in the description of prototype testing (see 322.4(a)).
322.3 Critical Parameters and “Worst Case” Conditions
a.
322.4

321.5

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

Prototype Testing
a.

Describe the direct test method (i.e., one that actually compares the
alignment of the parameters in the requirement) employed in testing
and measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.
b.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.
If any test used to monitor compliance does not actually compare the
alignment of the parameters in the requirement, explain why it is an
accurate indication of compliance with this requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

59
FORM FDA 3626 (1/14)

322.6

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 322.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 322.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 322.5 with respect to assembler testing. Note: The information
requested in 322.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

60
FORM FDA 3626 (1/14)

323.0 X-RAY FIELD SIZE DETERMINATION FOR MAMMOGRAPHIC EQUIPMENT
323.1

Requirement
Mammographic equipment shall be provided with means to limit the useful
beam such that the x-ray field at the plane of the image receptor does not
extend beyond any edge of the image receptor at any designated SID except
the edge of the image receptor designed to be adjacent to the chest wall
where the x-ray field may not extend beyond this edge by more than 2 percent
of the SID. Permanent, clearly legible markings shall indicate the image
receptor size and maximum SID for which each aperture is designed (see
1020.31(f)(3)).

323.2 Applicability
This requirement is applicable to beam-limiting devices. Similar models of a
single component type may be grouped for presentation of test results
applicable to this requirement when the technical basis for this grouping is
clearly stated in the description of prototype testing (see 323.4(a)).
323.3 Critical Parameters and “Worst Case” Conditions
a.
b.
c.
323.4

323.5

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.
The test results must include data for each aperture size at the maximum
designated SID.
Since the SID is used for calculating the compliance values of this
requirement, the accuracy of the SID measurement must be verfied.

Prototype Testing
a.

Describe the direct test method (i.e., one that actually compares the
alignment of the parameters in the requirement) employed in testing
and measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.
b.

Submit the technical data that supports the use of the test in b.

61
FORM FDA 3626 (1/14)

322.6

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 323.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 323.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 323.5 with respect to assembler testing. Note: The information
requested in 323.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

62
FORM FDA 3626 (1/14)

324.0 X-RAY FIELD SIZE DETERMINATION FOR RADIOGRAPHIC EQUIPMENT
NOT LISTED IN 318.0, 319.0, 320.0, 321.0, OR 323.0
324.1

Requirement
Radiographic x-ray systems other than: (a) stationary general purpose
systems; (b) systems designed for one image receptor size and SID; (c) spotfilm devices; (d) mobile equipment; and (e) equipment designed for use with
intraoral image receptors shall be provided with means to limit the x-ray beam
such that when the axis of the x-ray beam is perpendicular to the plane of the
image receptor, the dimensions of the x-ray field shall not exceed the
corresponding dimensions of the image receptor by more than 2 percent of
the SID, or shall be provided with means to both size and align the x-ray field
such that the x-ray field at the plane of the image receptor does not extend
beyond any edge of the image receptor (see 1020.31(f)(4)).

324.2 Applicability
This requirement is applicable to any beam-limiting devices. Similar models of
a single component type may be grouped for presentation of test results
applicable to this requirement when the technical basis for this grouping is
clearly stated in the description of prototype testing (see 324.4a).
324.3 Critical Parameters and “Worst Case” Conditions

324.4

324.5

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

The test results must include data for each aperture size.

Since the SID is used for calculating the compliance values of this
requirement, the accuracy of the SID measurement must be verfied.

Prototype Testing
a.

Describe the direct test method (i.e., one that actually compares the
alignment of the parameters in the requirement) employed in testing
and measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.
b.

63
FORM FDA 3626 (1/14)

324.6

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

For each test method in 324.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 324.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 324.5 with respect to assembler testing. Note: The information
requested in 324.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

64
FORM FDA 3626 (1/14)

325.0 TRANSMISSION LIMIT FOR IMAGE RECEPTOR SUPPORT DEVICES FOR
MAMMOGRAPHIC X-RAY SYSTEMS
325.1

Requirement
The transmission of the primary beam through any image receptor support
provided with the mammographic x-ray system shall be limited such that the
exposure 5 centimeters from any accessible surface beyond the plane of the
image receptor supporting device does not exceed 0.1 milliroentgen for each
activation of the tube (see 1020.31(l)).

325.2 Applicability
This requirement is applicable to mammographic image receptor supporting
devices. Similar models of a single component type may be grouped for
presentation of test results applicable to this requirement when the technical
basis for this grouping is clearly stated in the description of prototype testing
(see 325.4(a)).
325.3 Critical Parameters and “Worst Case” Conditions
a.
325.4

325.5

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits for any test must be sufficiently restrictive to assure
compliance with the standard.

Prototype Testing
a.

Describe the direct test method (i.e., one that actually measures x
radiation) employed in testing and measuring each model with respect to
this requirement.

Identify the instrument(s) used for the test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

Provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

Production Testing
a.
b.

Describe all methods employed in direct and indirect testing of each
model with respect to this requirement.
If any test used to monitor compliance does not actually measure x
radiation, explain why it is an accurate indication of compliance with this
requirement.

Submit the technical data that supports the use of the test in b.

Provide a copy of the detailed instructions for performing each test.
Enclose in APPENDIX I.

Identify the instrument(s) used for each test by manufacturer and model
number. Answer the questions in section 401.0, PART 400 for this
instrument(s).

65
FORM FDA 3626 (1/14)

325.6

For each test method in 325.5(a), give the page number of your detailed
instructions for performing the test where the rejection limits are
specified.

For each test method in 325.5(a), provide sample raw test data.

If the actual compliance value is calculated from the raw test data,
provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.

If you do not test 100 percent of the produced models, answer the
questions in section 402.0, PART 400.

Assembler Testing
a-i. If test instructions are provided to the assembler, answer the questions
in 325.5 with respect to assembler testing. Note: The information
requested in 325.6(d) (i.e., copy of detailed instructions for performing
each test) should have already been provided in APPENDIX B.

66
FORM FDA 3626 (1/14)

PART 400 - COMMON ASPECTS
401.0 INSTRUMENTATION
401.1 Radiation Measurement
a.

Describe each radiation measurement instrument that you reefer to in
PART 300, giving the following: manufacturer and model number if the
instrument is commercially available; type of instrument; precision;
accuracy; response time, energy dependence; angular response;
exposure rate dependence; ranges; and effective measurement area.

Describe the procedures used for calibration of each instrument
including the interval of time between calibrations.

How do you assure proper day-to-day operation of each instrument?

401.2 Illuminance and Contrast Measurement
a.

Describe each illuminance and/or contrast measurement instrument that
you refer to in PART 300, giving the following: manufacturer and model
number if the instrument is commercially available; type of measuring
instrument; precision; accuracy; and ranges.

Describe the procedures used for calibration of each instrument
including the interval of time between calibrations.

How do you assure proper day-to-day operation of each instrument?

401.3 Electrical Measurement
a.

Describe each electrical measurement instrument that you referred to in
PART 300, giving the following: type of instrument; manufacturer and
model number if the instrument is commercially available; rated
accuracy; precision; ranges; and response time. If any number of
commercially available instruments with certain basic characteristics
may be used, it is sufficient to state the minimum accuracy, precision,
ranges, response time, and so forth, of the class of instruments that will
be used. If any instrument is unique or of special manufacture then the
manufacturer and model number should be stated.

Describe the procedures used for calibration of each instrument
including the interval of time between calibrations.

Show where each instrument listed in 401.3(a) is connected during
testing with the use of a schematic diagram.
401.4 Other Measurement
a.

Describe each measurement instrument (other than radiation,
illuminance and contrast, or electrical) that you refer to in PART 300,
giving the following: type of instrument; manufacturer and model
number if the instrument is commercially available; rated accuracy;
precision; and ranges. If any number of commercially available
instruments with certain basic characteristics may be used, it is sufficient
to state the minimum accuracy, precision ranges, and so forth, of the
class of instruments that will be used. If any instrument is unique or of

67
FORM FDA 3626 (1/14)

special manufacture, however, then the manufacturer and model number
number should be stated.
b.

Describe the procedures used for calibration of each instrument including
the interval of time between calibrations.)

402.0 SAMPLING
a.

Describe the sampling plan used and provide the parameters of the plan
(e.g., lot size, sample size, rejection criterion).

Describe the procedures used for selecting the sample and indicate how
randomness is assured.

Describe the action taken if the sampling plan leads to a rejection
decision.

68
FORM FDA 3626 (1/14)

File Type	application/pdf
File Title	FORM FDA 3627
Subject	A Guide for the Submission of Initial Reports on Computed Tomography X ray Systems
Author	PSC Graphics
File Modified	2014-02-06
File Created	2010-12-07