POK
- Product code
- POK
- Device name
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.2060
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 15
- Summaries archived here
- 13 (direct download)
- 510(k) clearances (all years, FDA)
- 23 (all years; only the last 3 years are listed here)
FDA classification definition
Assist users in characterizing lesions identified on acquired medical images
510(k) clearances, last 3 years (15)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253884 | 2026-07-02 | Koios Medical, Inc. | Koios DS (3.8) | |
| K261519 | 2026-06-04 | Sonio | Sonio Suspect | |
| K254161 | 2026-03-27 | GE Medical Systems Ultrasound & Primar… | Automated Aortic Stenosis Software (AutoAS) | |
| K251769 | 2026-01-30 | Precision Medical Ventures, Inc. Dba R… | RevealAI-Lung | |
| K252294 | 2025-12-08 | Brightheart | Fetal EchoScan (v1.2) | |
| K250221 | 2025-07-01 | Circle Cardiovascular Imaging, Inc. | StrokeSENS ASPECTS Software Application | FDA |
| K251071 | 2025-05-02 | Brightheart | Fetal EchoScan (v1.1) | |
| K243614 | 2025-02-21 | Sonio | Sonio Suspect | |
| K243294 | 2025-02-14 | Brainomix Limited | Brainomix 360 e-ASPECTS | |
| K242130 | 2024-11-15 | Koios Medical, Inc. | Koios DS | FDA |
| K242342 | 2024-11-14 | Brightheart | Fetal EchoScan | |
| K241245 | 2024-10-04 | Echo IQ, Ltd. | EchoSolv AS | |
| K234141 | 2024-08-01 | Aisap | AISAP Cardio V1.0 | |
| K233342 | 2024-03-15 | Avicenna.Ai | CINA-ASPECTS | |
| K232156 | 2024-01-19 | Ischemaview, Inc. | Rapid ASPECTS (v3) |
Official FDA classification page: POK
Classification and pathway per current FDA publications. Data from openFDA (CC0).