Cleared in 2022
Radiology AI devices with a 2022 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
aPROMISE X
🇸🇪EXINI Diagnostics AB
System, Image Processing, Radiological
EFAI RTSuite CT HN-Segmentation System
Ever Fortune.Ai, Co., Ltd.
RT auto-contouring
Philips Incisive CT
🇨🇳Philips Healthcare (Suzhou) Co., Ltd.
System, X-Ray, Tomography, Computed
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
HealthOST
NanoxAI Ltd.
System, X-Ray, Tomography, Computed
Videa Caries Assist
🇺🇸VideaHealth Inc.
Analyzer, Medical Image
AI-Rad Companion Brain MR
🇩🇪Siemens Healthcare GmbH
MR image reconstruction/enhancement
RayStation 11B
🇸🇪RaySearch Laboratories AB (PUBL)
System, Planning, Radiation Therapy Treatment
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
INT Contour
🇺🇸Carina Medical LLC
System, Planning, Radiation Therapy Treatment
ClariPulmo
🇰🇷ClariPi Inc.
System, Image Processing, Radiological
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
MRCAT Head & Neck
🇫🇮Philips Oy
System, Planning, Radiation Therapy Treatment
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Ever Fortune.Ai, Co., Ltd.
MR image reconstruction/enhancement
MAGNETOM Avanto Fit
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
🇯🇵Canon Medical Systems Corporation
System, Imaging, Pulsed Doppler, Ultrasonic
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Customize
3D-Side SA
MR image reconstruction/enhancement
BriefCase
🇮🇱Aidoc Medical , Ltd.
Lesion detection/diagnosis software
Arterys MICA
🇺🇸Arterys, Inc.
MR image reconstruction/enhancement
CardIQ Suite
🇫🇷GE Medical Systems SCS
System, X-Ray, Tomography, Computed
ClearRead Xray Pneumothorax
Riverain Technologies, Inc.
Lesion detection/diagnosis software
Second Opinion
🇺🇸Pearl, Inc.
Analyzer, Medical Image
Aidoc BriefCase-Triage
🇮🇱Aidoc
Triage & notification (CADt)
BoneView
🇨🇳Gleamer
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
MAGNETOM Vida with syngo MR XA50A
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
Annalise Enterprise CXR Triage Pneumothorax
🇦🇺Annalise.ai
Lesion detection/diagnosis software
Viz ANEURYSM, Viz ANX
🇺🇸Viz.ai, Inc.
Lesion detection/diagnosis software
Deep Learning Image Reconstruction
🇺🇸Ge Medical Systems, LLC
System, X-Ray, Tomography, Computed
