Specialty

FDA-cleared AI radiology devices

The FDA's AI-enabled device list has 1,230 devices whose lead review panel is Radiology, 76.2% of all 1,614 listed devices. They come from 551 companies. The first decision was on June 26, 1998 and the most recent on June 29, 2026.

1,230AI devices
432Companies
1998First decision
2026-06-29Latest decision

Guides for radiology

Top radiology AI devices20261352025254202418320231782022138202111020209920195120184020171620161120145

Trend: devices per year

1998: 22001: 12002: 12008: 22011: 12012: 22014: 52015: 12016: 112017: 162018: 402019: 512020: 992021: 1102022: 1382023: 1782024: 1832025: 2542026: 135
'98'02'11'14'16'18'20'22'24'26
FDA-cleared AI radiology devices per year: 1998 2, 2001 1, 2002 1, 2008 2, 2011 1, 2012 2, 2014 5, 2015 1, 2016 11, 2017 16, 2018 40, 2019 51, 2020 99, 2021 110, 2022 138, 2023 178, 2024 183, 2025 254, 2026 135

Top companies

Most common product codes

QIH305 devicesLLZ161 devicesIYN124 devicesJAK103 devicesLNH100 devicesQAS86 devicesQKB46 devicesMYN43 devices

All 1,230 devices, newest first

Showing the 300 most recent. Use search to filter all 1,230.

Frequently asked questions

How many FDA-cleared AI radiology devices are there?

As of the FDA list updated through June 29, 2026, 1,230 AI-enabled devices have Radiology as their lead review panel (76.2% of the list).

Which companies have the most AI radiology devices?

Siemens Medical Solutions USA, Inc. (56), Canon Medical Systems Corporation (42), Aidoc Medical, Ltd. (30) have the most AI-enabled radiology devices on the FDA list.

Which year had the most AI radiology authorizations?

2025 had the most, with 254 devices.

Which FDA pathways are used for AI radiology devices?

510(k): 1212; De Novo: 9; PMA: 9.

What was the most recent AI radiology device on the list?

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) from Agada Medical, Ltd. (K253628), with a decision dated June 29, 2026.