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.
ProFound AI Software V2.1
🇺🇸iCAD, Inc.
Breast CAD (tomosynthesis)
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
🇺🇸Omega Medical Imaging, LLC
System, X-Ray, Fluoroscopic, Image-Intensified
Syngo.Via RT Image Suite
🇺🇸Siemens Medical Solutions USA, Inc.
System, Planning, Radiation Therapy Treatment
SubtleMR
🇺🇸Subtle Medical, Inc.
System, Image Processing, Radiological
SIS Software Version 3.6.0
Surgical Information Sciences, Inc.
System, Image Processing, Radiological
AI-Rad Companion (Cardiovascular)
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
D2P
3D Systems, Inc.
System, Image Processing, Radiological
Clarius Ultrasound Scanner
🇨🇦Clarius Mobile Health Corp.
System, Imaging, Pulsed Doppler, Ultrasonic
Critical Care Suite
🇺🇸Ge Medical Systems, LLC
Lesion detection/diagnosis software
aBSI
🇸🇪EXINI Diagnostics AB
System, Image Processing, Radiological
AI-Rad Companion (Pulmonary)
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
iNtuition-Structural Heart Module
🇺🇸Terarecon,Inc.
System, Image Processing, Radiological
DeepCT
Deep01 Limited
Triage & notification (CADt)
RayCare 2.3
🇸🇪RaySearch Laboratories AB (PUBL)
System, Planning, Radiation Therapy Treatment
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Koios DS for Breast
🇺🇸Koios Medical, Inc.
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
LiverMultiScan (LMSv3)
Perspectum Diagnostics Ltd
System, Nuclear Magnetic Resonance Imaging
RayStation
🇸🇪RaySearch Laboratories AB (PUBL)
System, Planning, Radiation Therapy Treatment
ClariCT.AI
🇰🇷ClariPi Inc.
System, Image Processing, Radiological
HealthICH
Zebra Medical Vision Ltd.
Triage & notification (CADt)
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
SurgicalAR
🇺🇸MEDIVIS, Inc.
System, Image Processing, Radiological
HealthPNX
Zebra Medical Vision Ltd.
Lesion detection/diagnosis software
Lung Vision System
🇮🇱Body Vision Medical Ltd.
System, Image Processing, Radiological
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Deep Learning Image Reconstruction
🇺🇸Ge Medical Systems, LLC
System, X-Ray, Tomography, Computed
Bone VCAR (BVCAR)
🇫🇷GE Medical Systems SCS
System, X-Ray, Tomography, Computed
SIS Software version 3.3.0
Surgical Information Sciences, Inc.
System, Image Processing, Radiological
cmTriage
🇺🇸CureMetrix, Inc.
Lesion detection/diagnosis software
