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.
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
🇨🇳Shenzhen Mindray Bio-Medical Electronics Co.,LTD
System, Imaging, Pulsed Doppler, Ultrasonic
Clarius Ultrasound Scanner
🇨🇦Clarius Mobile Health Corp.
System, Imaging, Pulsed Doppler, Ultrasonic
Lunit INSIGHT CXR Triage
🇰🇷Lunit, Inc.
Lesion detection/diagnosis software
Critical Care Suite with Endotracheal Tube Positing AI algorithm
🇺🇸Ge Medical Systems, LLC
MR image reconstruction/enhancement
Advanced Algorithms for Treatment Management Applications (AATMA)
🇸🇪Elekta Solutions AB
RT auto-contouring
FlightPlan for Liver
🇫🇷GE Medical Systems SCS
System, Image Processing, Radiological
Contour ProtegeAI
🇺🇸Mim Software, Inc.
RT auto-contouring
SwiftMR
🇰🇷Airs Medical, Inc.
System, Image Processing, Radiological
StrokeSENS LVO
Circle Neurovascular Imaging, Inc
Triage & notification (CADt)
VBrain-OAR
Vysioneer Inc.
RT auto-contouring
SubtlePET
🇺🇸Subtle Medical, Inc.
System, Tomography, Computed, Emission
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
🇩🇪Philips Medical Systems
System, Imaging, Pulsed Doppler, Ultrasonic
Deep Learning Image Reconstruction
🇯🇵Ge Healthcare Japan Corporation
System, X-Ray, Tomography, Computed
Intelligent NR
🇯🇵Canon Inc.
Solid State X-Ray Imager (Flat Panel/Digital Imager)
HealthCCSng
Zebra Medical Vision Ltd.
System, X-Ray, Tomography, Computed
ClariSIGMAM
🇰🇷ClariPi Inc.
MR image reconstruction/enhancement
Versana Premier
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
Aquilion Exceed LB
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
HERA W9, HERA W10 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
V8 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
AmCAD-UT
🇹🇼AmCad BioMed Corporation
MR image reconstruction/enhancement
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
🇩🇪Philips Medical Systems
System, Imaging, Pulsed Doppler, Ultrasonic
RayStation 11.0
🇸🇪RaySearch Laboratories AB (PUBL)
System, Planning, Radiation Therapy Treatment
AI Segmentation
🇺🇸Varian Medical Systems, Inc.
System, Planning, Radiation Therapy Treatment
Auto Lung Nodule Detection
🇰🇷Samsung Electronics Co.,Ltd.
Analyzer, Medical Image
EndoNaut
Therenva SAS
Interventional Fluoroscopic X-Ray System
RBknee
🇩🇰Radiobotics ApS
System, Image Processing, Radiological
Discovery MI Gen2
🇺🇸Ge Medical Systems, LLC
System, Tomography, Computed, Emission
TruSPECT Radiological Image Processing Station
🇮🇱Spectrum Dynamics Medical, Ltd.
System, Image Processing, Radiological
InferRead CT Stroke.AI
🇨🇳Infervision Medical Technology Co., Ltd.
Triage & notification (CADt)
