FDA-cleared AI devices for radiology 2018
2018 has 40 radiology AI devices, 150% more than 2017 (16). That is 3.3% of the 1,230 radiology devices on the FDA list, and 61.5% of all AI-device decisions dated 2018. The most active were Arterys, Inc. (2), GE Medical Systems Ultrasound and Primary Care Diagnostics (2), Quantib B.V. (2). The newest is AmCAD-UO from AmCad BioMed Corporation, decided on December 28, 2018.
Companies in 2018
By month
Product codes
LLZSystem, Image Processing, Radiological21IYNSystem, Imaging, Pulsed Doppler, Ultrasonic4QASRadiological Computer-Assisted Triage And Notification Software3JAKSystem, X-Ray, Tomography, Computed2QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2IYOSystem, Imaging, Pulsed Echo, Ultrasonic1JAASystem, X-Ray, Fluoroscopic, Image-Intensified1KPSSystem, Tomography, Computed, Emission1All 40 devices
- AmCAD-UOAmCad BioMed Corporation · Radiology
- Quantib NDQuantib BV · Radiology
- iSchemaView RAPIDiSchemaView, Inc. · Radiology
- vascuCAPElucid Bioimaging Inc. · Radiology
- Centricity Universal ViewerGE Healthcare · Radiology
- PowerLook Tomo Detection V2 SoftwareiCAD Inc. · Radiology
- AMRA ProfilerAMRA Medical AB · Radiology
- FerriSmart Analysis SystemResonance Health Analysis Services Pty Ltd · Radiology
- SubtlePETSubtle Medical, Inc. · Radiology
- TransparaScreenPoint Medical BV · Radiology
- Vitrea CT Brain PerfusionVital Images, Inc. · Radiology
- icobrainicometrix NV · Radiology
- NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinePoint Medical, Inc. · Radiology
- AccipiolxMaxQ-Al Ltd. · Radiology
- Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- Arterys MICAArterys Inc. · Radiology
- Ziostation2Ziosoft, Inc. · Radiology
- Volpara Imaging SoftwareVolpara Health Technologies Limited · Radiology
- BriefCaseAidoc Medical, Ltd. · Radiology
- Quantitative Total Extensible Imaging (QTxI)AIQ Solutions, Inc. · Radiology
- UscanEchoNous, Inc. · Radiology
- Workflow BoxMirada Medical Ltd. · Radiology
- DenSeeMammoStatlife · Radiology
- EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc. · Radiology
- HealthCCSZebra Medical Vision Ltd. · Radiology
- LungQ SoftwareThirona Corporation · Radiology
- OsteoDetectImagen Technologies, Inc. · Radiology
- Clarius Ultrasound ScannerClarius Mobile Health Corp. · Radiology
- Ventripoint Medical System Plus (VMS+)Ventripoint Diagnostics, Ltd. · Radiology
- VenueGE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- Viz CTPViz.ai, Inc. · Radiology
- DR 800 with MUSICA DynamicAgfa HealthCare N.V. · Radiology
- Quantib BrainQuantib BV · Radiology
- iQMRMedic Vision - Imaging Solutions Ltd · Radiology
- DM-DensityDensitas, Inc. · Radiology
- ContaCTViz.Al, Inc. · Radiology
- UNiD Spine AnalyzerMedicrea International · Radiology
- Arterys Oncology DLArterys Inc. · Radiology
- Illumeo SystemPhilips Medical Systems Technologies, Ltd. · Radiology
- cNeuro cMRICombinostics Oy · Radiology
Frequently asked questions
How many FDA-cleared AI radiology devices were there in 2018?
40 AI-enabled radiology devices have a final decision dated 2018, from 37 companies.
How does 2018 compare with 2017 for AI radiology devices?
2018 has 40 radiology AI devices, 150% more than 2017 (16).
Which companies cleared the most AI radiology devices in 2018?
Arterys, Inc. (2), GE Medical Systems Ultrasound and Primary Care Diagnostics (2), Quantib B.V. (2).
What was the most recent AI radiology device in 2018?
AmCAD-UO from AmCad BioMed Corporation (K180867), decided on December 28, 2018. Product code LLZ.
Which product codes were most common for AI radiology devices in 2018?
LLZ (System, Image Processing, Radiological): 21; IYN (System, Imaging, Pulsed Doppler, Ultrasonic): 4; QAS (Radiological Computer-Assisted Triage And Notification Software): 3.
Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2018,” https://ai-device-radar.vercel.app/specialty/radiology/2018 (FDA list through 2026-06-29).