Artificial Intelligence-Enabled Medical Devices

US Food and Drug Administration. 'Artificial Intelligence-En

1,614 listed devices, 1,230 in radiology, 1,553 with 510(k) submission numbers; the FDA states the list is not a comprehensive resource; a 510(k) demonstrates a device is 'substantially equivalent' to a legally marketed device.

1,614 listed devices, 1,230 in radiology, 1,553 with 510(k) submission numbers; the FDA states the list is not a comprehensive resource; a 510(k) demonstrates a device is 'substantially equivalent' to a legally marketed device.

Written from the full text read 2026-10-15.

What our sources record

Reproduced as it was written when this source was checked, figures and all.

list, page modified 4 September 2026, and 'Premarket Notification 510(k)'. Full text read: 1,614 listed devices, 1,230 in radiology, 1,553 with 510(k) submission numbers; the FDA states the list is not a comprehensive resource; a 510(k) demonstrates a device is 'substantially equivalent' to a legally marketed device.