FDA 510(k) Radiology Devices
About Radiology Devices
FDA 510(k) radiology devices include medical imaging systems and radiation therapy equipment. The FDA review panel code is RA.
Key modalities covered:
- X-ray and fluoroscopy - digital radiography, fluoroscopy systems and C-arms
- Computed tomography (CT) - whole-body and dedicated CT scanners
- Magnetic resonance imaging (MRI) - 1.5T, 3T and extremity MRI systems
- Ultrasound imaging - diagnostic, point-of-care and intravascular ultrasound
- Radiation therapy - linear accelerators, brachytherapy and treatment planning
- Nuclear medicine - PET, SPECT and gamma camera systems
FDA 510(k) Cleared Radiology Devices
This page lists all 789 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.
- 789 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 116 days.
- Records available from 2021 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 789 medical devices in the Radiology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 789 were cleared as substantially equivalent to a predicate device. Average FDA review time: 116 days. Records from 2021 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to radiology
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
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.
Looking for a specific radiology device? Search by device name, K-number or manufacturer.
Search all Radiology 510(k) devices