FDA 510(k) radiology devices include medical imaging systems and radiation therapy equipment. The FDA review panel code is RA.
Key modalities covered:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 150d |
| All-time average (cleared) | 107d |
| Not Substantially Equivalent (denied) | 258d |
Recent Radiology submissions have taken longer than the historical average - 150 days in the last 2 years vs 107 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 258 days before receiving a Not Substantially Equivalent determination.
This page lists all 15695 medical devices in the Radiology specialty that have been submitted to the FDA through the 510(k) premarket notification process. CT, MRI, X-ray, ultrasound imaging systems and radiation therapy devices.
This page lists 15695 medical devices in the Radiology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 15676 were cleared as substantially equivalent to a predicate device. Average FDA review time: 107 days. Records from 1976 to the present.
You can use this list to:
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
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