X-ray performed on a GE Optima 646 DR system. The FDA has updated its radiology reporting forms on its website.

July 24, 2017 — The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has received approval from the Office of Management and Budget to extend all Radiation Safety reporting forms an additional three years until July 31, 2020. The CDRH will be updating the expiration dates on all the forms, but until that it finished, imaging centers are advised to continue to use the reporting forms found at www.fda.gov/AboutFDA/ReportsManualsForms/Forms/RadiologicalHealthForms/default.htm.  

The CDRH said this includes all annual report forms, which are due by Sept. 1, 2017.  

Manufacturers of radiation-emitting electronic products should check Table 1 in 21 CFR 1002.1 to determine whether its product area is subject to annual reporting, visit www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1002.1.
 
See FDA Radiation-Emitting Products homepage with OMB notice under Spotlight: www.fda.gov/Radiation-EmittingProducts/default.htm.
 
For questions, contact the FDA at [email protected].


Related Content

News | FDA

March 24, 2026 — MARS Bioimaging, a New Zealand–headquartered medical device company, has received U.S. Food and Drug ...

Time March 25, 2026
arrow
News | Pediatric Imaging

March 17, 2026 – OXOS Medical recently announced that its MC2 portable X-ray system is now cleared for pediatric imaging ...

Time March 23, 2026
arrow
News | Radiology Imaging

March 23, 2026 — Samsung Medison hsa announced that its U.S. medical imaging businesses, previously operating as ...

Time March 23, 2026
arrow
News | MRI Breast | Breast cancer, dense breast, MRI

March 2, 2026 — A collaborative modeling study found that adding biennial breast magnetic resonance imaging (MRI) to ...

Time March 20, 2026
arrow
News | Radiology Business

March 1, 2026 — A new study from the Harvey L. Neiman Health Policy Institute found that practice turnover (i.e ...

Time March 19, 2026
arrow
News | Radiology Business

March 12, 2026 — DelveInsight's has released its latest Diagnostic Imaging Equipment Market Insights report. The in ...

Time March 13, 2026
arrow
News | Women's Health

March 4, 2026 — QT Imaging Holdings recently announced that Mary W. Yamashita, MD will serve as medical advisor to the ...

Time March 06, 2026
arrow
News | Radiation Oncology

March 4, 2026 — Lunit has announced that 21 studies featuring its AI solutions will be presented at the European ...

Time March 05, 2026
arrow
News | Artificial Intelligence

March 2, 2026 — RadNet, Inc. has acquired Gleamer SAS, a radiology AI company based in Paris, France. Gleamer will be ...

Time March 03, 2026
arrow
News | HIMSS

March 3, 2026 — MedDream will present its cloud-native, AI-ready universal DICOM viewer in the Amazon Web Services (AWS) ...

Time March 03, 2026
arrow
Subscribe Now