AI devices with FDA product code POK — Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Product code POK (“Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer” in openFDA) covers 22 devices on the FDA AI-enabled list, from 17 companies. Most are reviewed by the Radiology panel (22). The most recent decision was Sonio Suspect on June 4, 2026.
22AI devices
15Companies
2017First decision
2026-06-04Latest decision
Trend: devices per year
201720192020202120222023202420252026
Top companies
All 22 devices, newest first
- Sonio SuspectSonio · Radiology
- Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
- RevealAI-LungPrecision Medical Ventures, Inc. Dba Revealdx · Radiology
- Fetal EchoScan (v1.2)Brightheart · Radiology
- StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging Inc. · Radiology
- Fetal EchoScan (v1.1)BrightHeart · Radiology
- Sonio SuspectSonio · Radiology
- Brainomix 360 e-ASPECTSBrainomix Limited · Radiology
- Koios DSKoios Medical, Inc. · Radiology
- Fetal EchoScanBrightHeart · Radiology
- EchoSolv ASEcho IQ Ltd · Radiology
- AISAP Cardio V1.0Aisap · Radiology
- CINA-ASPECTSAvicenna.AI · Radiology
- Rapid ASPECTS (v3)iSchemaView, Inc. · Radiology
- Brainomix 360 e-ASPECTSBrainomix Limited · Radiology
- Avenda Health AI Prostate Cancer Planning SoftwareAvenda Health, Inc. · Radiology
- Koios DSKoios Medical, Inc. · Radiology
- Optellum Virtual Nodule Clinic, Optellum software, Optellum platformOptellum Ltd · Radiology
- EchoGo ProUltromics Ltd · Radiology
- Rapid ASPECTSiSchemaView Inc. · Radiology
- Koios DS for BreastKoios Medical, Inc. · Radiology
- QuantXQuantitative Insights, Inc · Radiology