Three in four AI-listed devices are in the radiology panel; its share peaked in 2020

Source

• FDA, Artificial Intelligence-Enabled Medical Devices (opens in a new tab)The list (CSV), content current as of September 4, 2026: Date of Final Decision, Submission Number, Panel (Lead), Primary Product Code

Method

Kent Applied joined each device on the FDA's AI-Enabled Medical Device List (the version current as of September 4, 2026: 1,614 devices with final decisions from September 29, 1995, to June 29, 2026) to its record in the FDA's 510(k), PMA and product classification files by submission number. The FDA says the list is not a comprehensive resource of AI-enabled devices. The panel is the list's "Panel (Lead)" field, the FDA's medical specialty grouping for the type of device, so it describes the device type and not the doctors who use it. All other panels covers 15: Anesthesiology, Gastroenterology-Urology, Hematology, Pathology, Ophthalmic, General and Plastic Surgery, Clinical Chemistry, Orthopedic, Dental, Microbiology, General Hospital, Obstetrics and Gynecology, Clinical Toxicology, Ear Nose & Throat, Immunology. 2026 runs from January to June.

Published

October 30, 2026

Free to share and embed with credit to Kent Applied (CC BY 4.0). The source data keeps its own terms.