More than half of the FDA's 2025 clearances tagged radiology were for AI-listed devices
Share of the 2025 510(k) clearances tagged with each FDA review committee that are on the FDA's list of AI-enabled devices, the 11 committees with 100 or more clearances (their count in brackets)
Show the numbers as a table
| Item | Share of the committee's 2025 510(k) clearances on the AI list | Note |
|---|---|---|
| Radiology (467) | 54.0% | 252 of 467 clearances |
| Cardiovascular (301) | 9.0% | 27 of 301 clearances |
| Anesthesiology (122) | 5.7% | 7 of 122 clearances |
| Neurology (209) | 5.3% | 11 of 209 clearances |
| Gastroenterology, urology (206) | 3.9% | 8 of 206 clearances |
| Orthopedic (482) | 2.3% | 11 of 482 clearances |
| Microbiology (123) | 0.8% | 1 of 123 clearances |
| General, plastic surgery (440) | 0.7% | 3 of 440 clearances |
| Dental (245) | 0.0% | 0 of 245 clearances |
| General hospital (200) | 0.0% | 0 of 200 clearances |
| Physical medicine (102) | 0.0% | 0 of 102 clearances |
About the data
- 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, 510(k) releasable files (opens in a new tab)pmn96cur.txt (October 26, 2026): DATERECEIVED, DECISIONDATE, DECISION, REVIEWADVISECOMM, TYPE
- 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 committee is the review advisory committee code the FDA's 510(k) file gives each clearance; its name is the FDA's description of the code. Eight committees with fewer than 100 clearances in 2025 are left off the chart and appear in the downloads; pathology (3 of 13) and hematology (3 of 22) have the highest shares among them.
- Published
Free to share and embed with credit to Kent Applied (CC BY 4.0). The source data keeps its own terms.
Related charts
- 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
Three in four AI-listed devices are in the radiology panel; its share peaked in 2020
FDA, Artificial Intelligence-Enabled Medical Devices - 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
40 devices on the FDA's AI list came through De Novo grants, each a new device type
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, product classification file; FDA, De Novo Classification Request
Sources for the figures above: FDA, De Novo Classification Request (opens in a new tab).
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