Radiology is the lead panel for 1,230 of the 1,614 devices on the FDA's AI-Enabled Medical Device List (76.2%), in the version current as of September 4, 2026, by Kent Applied's count.
76.2%
of the 1,614 devices on the FDA's AI-Enabled Medical Device List are listed under its radiology panel
Radiology is the lead panel for 1,230 of the 1,614 devices on the FDA's AI-Enabled Medical Device List (76.2%), in the version current as of September 4, 2026, by Kent Applied's count.
Cardiovascular is the panel for 154 (9.5%) and neurology for 73 (4.5%).
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. Verified October 2026.
Related charts
- From research
Three in four AI-listed devices are in the radiology panel; its share peaked in 2020
FDA, Artificial Intelligence-Enabled Medical Devices - From research
About one FDA 510(k) clearance in ten is now for a device on the AI list
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files - From research
More than half of the FDA's 2025 clearances tagged radiology were for AI-listed devices
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files - From research
A quarter of the devices on the FDA's AI list are filed under scanner product codes
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, product classification file
Related facts
54.0%
of the 510(k) clearances tagged with the FDA's radiology review committee in 2025 were for devices on its AI list
In 2025, 252 of the 467 510(k) clearances tagged with the FDA's radiology review committee (54.0%) were for devices on the FDA's AI-Enabled Medical Device List, by Kent Applied's count.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied408
of the 1,614 devices on the FDA's AI-Enabled Medical Device List are filed under a scanner's product code
408 of the 1,614 devices on the FDA's AI-Enabled Medical Device List (25.3%) are filed under the product code of a scanner, such as an ultrasound, CT or MRI system, by Kent Applied's grouping of 18 FDA product codes.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied40
of the 1,614 devices on the FDA's AI-Enabled Medical Device List were authorized through a De Novo grant
40 of the 1,614 devices on the FDA's AI-Enabled Medical Device List were authorized through a De Novo grant, by Kent Applied's count.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied
Book a 20-minute call
If a number like this one matters to your organization, talk it through with Tyler Kent.
Prefer to skip the call? Get a written proposal
Or email tyler@kentapplied.com.