22 devices · 17 companies · 2017 to 2026
Product code POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
22 devices under product code POK, 2017 to 2026, from 17 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (21 of 22 here), the regulation, and MAUDE report counts by product code.
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. 21 CFR 892.2060, Class II. Assist users in characterizing lesions identified on acquired medical images MAUDE held 1 adverse-event report against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Sonio SuspectK261519 · 510(k) | Sonio | Radiology | database entry | |
| Automated Aortic Stenosis SoftwareK254161 · 510(k) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Radiology | database entry | |
| RevealAI-LungK251769 · 510(k) | Precision Medical Ventures, Inc. Dba Revealdx | Radiology | database entry | |
| Fetal EchoScanK252294 · 510(k) | Brightheart | Radiology | database entry | |
| StrokeSENS ASPECTS Software ApplicationK250221 · 510(k) | Circle Cardiovascular Imaging Inc. | Radiology | database entry | |
| Fetal EchoScanK251071 · 510(k) | BrightHeart | Radiology | database entry | |
| Sonio SuspectK243614 · 510(k) | Sonio | Radiology | database entry | |
| Brainomix 360 e-ASPECTSK243294 · 510(k) | Brainomix Limited | Radiology | database entry | |
| Koios DSK242130 · 510(k) | Koios Medical, Inc. | Radiology | database entry | |
| Fetal EchoScanK242342 · 510(k) | BrightHeart | Radiology | database entry | |
| EchoSolv ASK241245 · 510(k) | Echo IQ Ltd | Radiology | database entry | |
| AISAP Cardio V1.0K234141 · 510(k) | Aisap | Radiology | database entry | |
| CINA-ASPECTSK233342 · 510(k) | Avicenna.AI | Radiology | database entry | |
| Rapid ASPECTSK232156 · 510(k) | iSchemaView, Inc. | Radiology | database entry | |
| Brainomix 360 e-ASPECTSK221564 · 510(k) | Brainomix Limited | Radiology | database entry | |
| Avenda Health AI Prostate Cancer Planning SoftwaK221624 · 510(k) | Avenda Health, Inc. | Radiology | database entry | |
| Koios DSK212616 · 510(k) | Koios Medical, Inc. | Radiology | database entry | |
| Optellum Virtual Nodule Clinic, Optellum softwarK202300 · 510(k) | Optellum Ltd | Radiology | database entry | |
| EchoGo ProK201555 · 510(k) | Ultromics Ltd | Radiology | database entry | |
| Rapid ASPECTSK200760 · 510(k) | iSchemaView Inc. | Radiology | database entry | |
| Koios DS for BreastK190442 · 510(k) | Koios Medical, Inc. | Radiology | database entry | |
| QuantXDEN170022 · De Novo | Quantitative Insights, Inc | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.