510(k) Radiology Devices

FDA 510(k) Cleared Radiology Devices

This page lists all 15384 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.

• 15365 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 106 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.