Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Radiology · 21 CFR 892.2060
Assist users in characterizing lesions identified on acquired medical images
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
21 firms currently registered for this product code
Koios Medical, Inc.
New York, NY, US
Echoiq Limited
Sydney New South Wales, AU
Ischemaview, Inc.
Golden, CO, US
Sonio
Paris, FR
Brightheart Sas
Paris, FR
Circle Cardiovascular Imaging Inc
Calgary Alberta, CA
Brainomix Limited
Oxford Oxfordshire, GB
Aisap Ltd
Ramat Gan Central, IL
Optellum Ltd
Oxford Oxfordshire, GB
Avenda Health Inc.
Culver City, CA, US
Philips Ultrasound Llc
BOTHELL, WA, US
Precision Medical Ventures, Inc. Dba Revealdx
Seattle, WA, US
Ultromics, Ltd.
Oxford Oxfordshire, GB
Philips Ultrasound Llc
Reedsville, PA, US
Avicenna.ai
La Ciotat Bouches-du-Rhone, FR
Ge Medical Systems Ultrasound And Primary Care Diagnostics, Llc
Waukesha, WI, US
510(k) clearances
23 clearances for this product code
- Koios Medical, Inc.Jul 2, 2026
K253884 · Koios DS (3.8)
- SonioJun 4, 2026
K261519 · Sonio Suspect
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCMar 27, 2026
K254161 · Automated Aortic Stenosis Software (AutoAS)
- Precision Medical Ventures, Inc. Dba RevealdxJan 30, 2026
K251769 · RevealAI-Lung
- BrightheartDec 8, 2025
K252294 · Fetal EchoScan (v1.2)
- Circle Cardiovascular Imaging, Inc.Jul 1, 2025
K250221 · StrokeSENS ASPECTS Software Application
- BrightheartMay 2, 2025
K251071 · Fetal EchoScan (v1.1)
- SonioFeb 21, 2025
K243614 · Sonio Suspect