FDA-cleared — AI devices
Radiology AI devices on the FDA's AI-Enabled Device List (the Radiology panel). The list is not comprehensive and lags publication of decision summaries. Information only, never clinical advice.
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
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
Voluson P6, Voluson P8
🇺🇸GE Healthcare
System, Imaging, Pulsed Doppler, Ultrasonic
SIGNA Artist Evo
🇨🇳GE Healthcare (Tianjin) Company Limited
System, Nuclear Magnetic Resonance Imaging
Rapid
iSchema View Inc.
System, Image Processing, Radiological
Micro C Medical Imaging System, M01
🇺🇸OXOS Medical, Inc.
System, X-Ray, Mobile
Revolution Ascend
🇯🇵Ge Healthcare Japan Corporation
System, X-Ray, Tomography, Computed
Contour ProtégéAI
🇺🇸Mim Software, Inc.
RT auto-contouring
syngo.CT Brain Hemorrhage
🇺🇸Siemens Medical Solutions USA, Inc.
Triage & notification (CADt)
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
🇯🇵Canon Medical Systems Corporation
System, Imaging, Pulsed Doppler, Ultrasonic
