Cleared in 2021
Radiology AI devices with a 2021 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
LiverSmart
🇦🇺Resonance Health Analysis Services Pty Ltd
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
BoneMRI
🇳🇱MRIguidance B.V
MR image reconstruction/enhancement
qXR-BT
🇮🇳Qure.Ai Technologies
MR image reconstruction/enhancement
BU-CAD
TaiHao Medical Inc.
Breast CAD (tomosynthesis)
EchoGo Core (2.0)
Ultromics Limited
MR image reconstruction/enhancement
VBrain
Vysioneer Inc.
RT auto-contouring
Koios DS
🇺🇸Koios Medical, Inc.
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
RT-Mind-AI
🇨🇳MedMind Technology Co., Ltd.
RT auto-contouring
HealthPPT
Zebra Medical Vision Ltd.
Lesion detection/diagnosis software
LVivo Seamless
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
Al-Rad Companion (Pulmonary)
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
Cydar EV (Series B) and Cydar EV Maps
🇬🇧Cydar Ltd.
Interventional Fluoroscopic X-Ray System
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
MammoScreen 2.0
🇺🇸Therapixel
Breast CAD (tomosynthesis)
OnQ Neuro
🇺🇸CorTechs Labs, Inc.
MR image reconstruction/enhancement
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
Soteria.AI
🇺🇸Omega Medical Imaging, LLC
Interventional Fluoroscopic X-Ray System
Lunit INSIGHT MMG
🇰🇷Lunit, Inc.
Breast CAD (tomosynthesis)
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
