Radiology · 2022

FDA-cleared AI devices for radiology 2022

2022 has 138 radiology AI devices, 25.5% more than 2021 (110). That is 11.2% of the 1,230 radiology devices on the FDA list, and 85.2% of all AI-device decisions dated 2022. The most active were Siemens Medical Solutions USA, Inc. (15), Aidoc Medical, Ltd. (10), GE Medical Systems Ultrasound and Primary Care Diagnostics (6). The newest is AVIEW from Coreline Soft Co.,Ltd., decided on December 23, 2022.

1382022 devices
82Companies
85.2%Of all 2022 AI devices
11.2%Of all radiology

Companies in 2022

By month

Jan: 14Feb: 10Mar: 9Apr: 16May: 13Jun: 14Jul: 15Aug: 11Sep: 12Oct: 8Nov: 8Dec: 8
JanFebMarAprMayJunJulAugSepOctNovDec
Radiology AI devices by month in 2022: Jan 14, Feb 10, Mar 9, Apr 16, May 13, Jun 14, Jul 15, Aug 11, Sep 12, Oct 8, Nov 8, Dec 8

Product codes

QIHAutomated Radiological Image Processing Software25LNHSystem, Nuclear Magnetic Resonance Imaging18IYNSystem, Imaging, Pulsed Doppler, Ultrasonic16JAKSystem, X-Ray, Tomography, Computed15QASRadiological Computer-Assisted Triage And Notification Software15LLZSystem, Image Processing, Radiological12QFMRadiological Computer-Assisted Prioritization Software For Lesions9QKBRadiological Image Processing Software For Radiation Therapy7

All 138 devices

All radiology devicesAll AI clearances in 2022Top radiology AI devices202111020231782026 radiology

Frequently asked questions

How many FDA-cleared AI radiology devices were there in 2022?

138 AI-enabled radiology devices have a final decision dated 2022, from 82 companies.

How does 2022 compare with 2021 for AI radiology devices?

2022 has 138 radiology AI devices, 25.5% more than 2021 (110).

Which companies cleared the most AI radiology devices in 2022?

Siemens Medical Solutions USA, Inc. (15), Aidoc Medical, Ltd. (10), GE Medical Systems Ultrasound and Primary Care Diagnostics (6).

What was the most recent AI radiology device in 2022?

AVIEW from Coreline Soft Co.,Ltd. (K214036), decided on December 23, 2022. Product code QIH.

Which product codes were most common for AI radiology devices in 2022?

QIH (Automated Radiological Image Processing Software): 25; LNH (System, Nuclear Magnetic Resonance Imaging): 18; IYN (System, Imaging, Pulsed Doppler, Ultrasonic): 16.

Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2022,” https://ai-device-radar.vercel.app/specialty/radiology/2022 (FDA list through 2026-06-29).