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.
408
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.
Some of them are software sold for a scanner, such as image reconstruction.
Sources: 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; FDA, product classification file (opens in a new tab), foiclass.txt (October 26, 2026): PRODUCTCODE, DEVICENAME. Verified October 2026.
Related charts
- 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 - 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
Three in four AI-listed devices are in the radiology panel; its share peaked in 2020
FDA, Artificial Intelligence-Enabled Medical Devices
Related facts
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.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied54.0%
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.
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
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