Document Type |
Form No. |
Form Name |
Instrument File |
URL |
Available Electronically? |
Can Be Submitted Electronically? |
Electronic Capability |
Form and Instruction |
FDA 3641 |
Guide for Filing Annual Reports for X-Ray Components and Systems
|
3641 Cabinet X-Ray Annual Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3643 |
Microwave Oven Products Annual Report
|
3643 MWO Annual Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3636 |
Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products
|
3636 Laser Annual Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3631 |
Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamp Products
|
3631 Sunlamp Annual Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3647 |
Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps
|
3647 Mercury Vapor Lamp Annual Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3645 |
Guide for Preparing Annual Reports for Ultrasonic Therapy Products
|
3645 Therapy Ultrasound Annual Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3649 |
Accidental Radiation Occurrence Report
|
3649 ARO Report form .pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3642 |
General Correspondence
|
3642 General Correspondence.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 2767 |
Notice of Availability of Sample Electronic Product
|
2767 Sample Availability form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 2877 |
Declaration for Imported Electronic Products Subject to Radiation Control Standards
|
2877 EPRC Imports form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3633 |
General Variance Application
|
3633 General Variance Application.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3635 |
LLS Notification
|
3635 LLS Notification.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 2579 |
Report of Assembly of a Diagnostic X-Ray System
|
2579 Assembler Report.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3626 |
A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components
|
3626 DX Product Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3627 |
A Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems
|
3627 CT Product Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3639 |
Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40
|
3639 Cabinet X-Ray Product Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3632 |
Guide for Preparing Product Reports for Lasers and Products Containing Lasers
|
3632 Laser Product Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3640 |
Reporting Guide for Laser Light Shows and Displays
|
3640 LLS Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3630 |
Guide for Preparing Product Reports on Sunlamps and Sunlamp Products
|
3630 Sunlamp Product Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3646 |
Mercury Vapor Lamp Products Radiation Safety Report
|
3646 Mercury Vapor Lamp Product Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3644 |
Guide for Preparing Product Reports for Ultrasonic Therapy Products
|
3644 Therapy Ultrasound Product Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3659 |
TV Product Report
|
3659 TV Product Report.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3660 |
Guidance for Preparing Reports on Radiation Safety of Microwave Ovens
|
3660 MWO Product Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3801 |
Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps
|
3801 Medical UV Lamp Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3629 |
General Abbreviated Report
|
3629 General Abbreviated Report.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3661 |
A Guide for the Submission of an Abbreviated Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use
|
3661 Abbrev X-Ray report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3662 |
A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use
|
3662 Abbrev Cephalometric report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3663 |
Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens)
|
3663 Abbrev Microwave report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3628 |
Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)
|
3628 General Annual Report (includes medical, analytical, industrial x-ray products) form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3634 |
TV Annual Report
|
3634 TV Annual Report.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3638 |
Guide for Filing Annual Reports for X-Ray Components and Systems
|
3638 DX Annual Report form.pdf
|
|
Yes |
Yes |
Fillable Fileable |
Form and Instruction |
FDA 3637 |
Laser OEM Component Report
|
3637 Laser OEM Component Report.pdf
|
|
Yes |
Yes |
Fillable Fileable |