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 (Engine)
🇺🇸Siemens Medical Solutions USA, Inc.
System, Image Processing, Radiological
SIGNA Premier
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
MRCP+ v1.0
Perspectum Diagnostics Ltd
System, Image Processing, Radiological
AmCAD-UO
🇹🇼AmCad BioMed Corporation
System, Image Processing, Radiological
Quantib ND
🇳🇱Quantib BV
System, Image Processing, Radiological
iSchemaView RAPID
🇺🇸iSchemaView, Inc.
System, Image Processing, Radiological
vascuCAP
Elucid Bioimaging Inc.
System, Image Processing, Radiological
Centricity Universal Viewer
🇺🇸GE Healthcare
System, Image Processing, Radiological
PowerLook Tomo Detection V2 Software
🇺🇸iCAD, Inc.
Breast CAD (tomosynthesis)
AMRA Profiler
🇸🇪AMRA Medical AB
System, Nuclear Magnetic Resonance Imaging
FerriSmart Analysis System
🇦🇺Resonance Health Analysis Services Pty Ltd
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
SubtlePET
🇺🇸Subtle Medical, Inc.
System, Tomography, Computed, Emission
Transpara
ScreenPoint Medical BV
Breast CAD (tomosynthesis)
Vitrea CT Brain Perfusion
Vital Images, Inc.
System, Image Processing, Radiological
icobrain
icometrix NV
System, Image Processing, Radiological
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
NinePoint Medical, Inc.
System, Imaging, Optical Coherence Tomography (Oct)
Accipiolx
MaxQ Al Ltd.
Triage & notification (CADt)
Vivid E80, Vivid E90, Vivid E95
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
Arterys MICA
🇺🇸Arterys, Inc.
System, Image Processing, Radiological
Ziostation2
🇯🇵Ziosoft, Inc.
System, Image Processing, Radiological
Volpara Imaging Software
Volpara Health Technologies Limited
System, Image Processing, Radiological
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Quantitative Total Extensible Imaging (QTxI)
AIQ Solutions, Inc.
System, Image Processing, Radiological
Uscan
🇺🇸EchoNous, Inc.
System, Imaging, Pulsed Echo, Ultrasonic
Workflow Box
Mirada Medical Ltd.
RT auto-contouring
DenSeeMammo
Statlife
System, Image Processing, Radiological
EchoMD Automated Ejection Fraction Software
Bay Labs, Inc.
System, Image Processing, Radiological
HealthCCS
Zebra Medical Vision Ltd.
System, X-Ray, Tomography, Computed
LungQ Software
Thirona Corporation
System, X-Ray, Tomography, Computed
OsteoDetect
🇺🇸Imagen Technologies, Inc
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
