# FDA's AI-enabled device list reaches 1,614 authorisations, 1,230 of them radiology

Page: https://flyvolo.ai/en/changes/ev-20260904-radiologist-1
Date: 2026-09-04 · Stage: Capability
Can this record move a task judgement? no
Occupation: https://flyvolo.ai/en/careers/radiologist

## Scope

United States only, and the list counts marketing authorisations, not installations: a cleared device may be running in a thousand hospitals or in none. Most of these are 510(k) clearances, which turn on substantial equivalence to an existing device rather than a trial, and each authorisation covers one narrow intended use — a triage flag, a measurement, a detection aid — not reading a study. The FDA states the list is not comprehensive and was assembled primarily by matching AI-related terms in the authorisation summaries, so both the total and the radiology share are floors rather than counts. Panel is the lead review panel, not the specialty that uses the device.

## Source

- U.S. Food and Drug Administration — AI-Enabled Medical Device List — https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices (primary source)

## What this means

As of September 2026 a regulator has reviewed and authorised 1,230 radiology AI devices for the US market, and radiology is three quarters of the whole AI-device list — far ahead of every other specialty. The tools exist, they have been through a premarket review, and they are legally sellable to hospitals.

## What it does not show yet

It does not say a single one of them is switched on anywhere. Authorisation is a permission, not an installation, and most of these are 510(k) clearances resting on equivalence to a device already on the market rather than on a trial. Nor does an authorisation cover reading a study: each one names a narrow intended use — flag this finding, measure this volume, triage this queue — with a radiologist still signing.

## How to verify it yourself

Open the list yourself and download the CSV: sort by Panel and count. Then pick one device with a name you recognise and open its FDA database entry — the intended-use statement will tell you, in one paragraph, how much narrower the authorisation is than the headline.


More: https://flyvolo.ai/llms.txt