FDA Product Code
FDA Product Code POK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2060
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253884 | Koios DS (3.8) | Koios Medical, Inc. | 2026-07-02 | Traditional | PDF ↗ |
| K261519 | Sonio Suspect | Sonio | 2026-06-04 | Special | PDF ↗ |
| K254161 | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-03-27 | Traditional | PDF ↗ |
| K251769 | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx | 2026-01-30 | Traditional | PDF ↗ |
| K252294 | Fetal EchoScan (v1.2) | Brightheart | 2025-12-08 | Traditional | PDF ↗ |
| K250221 | StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. | 2025-07-01 | Traditional | PDF ↗ |
| K251071 | Fetal EchoScan (v1.1) | Brightheart | 2025-05-02 | Special | PDF ↗ |
| K243614 | Sonio Suspect | Sonio | 2025-02-21 | Traditional | PDF ↗ |
| K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2025-02-14 | Traditional | PDF ↗ |
| K242130 | Koios DS | Koios Medical, Inc. | 2024-11-15 | Traditional | PDF ↗ |
| K242342 | Fetal EchoScan | Brightheart | 2024-11-14 | Traditional | PDF ↗ |
| K241245 | EchoSolv AS | Echo IQ, Ltd. | 2024-10-04 | Traditional | PDF ↗ |
| K234141 | AISAP Cardio V1.0 | Aisap | 2024-08-01 | Traditional | PDF ↗ |
| K233342 | CINA-ASPECTS | Avicenna.Ai | 2024-03-15 | Traditional | PDF ↗ |
| K232156 | Rapid ASPECTS (v3) | Ischemaview, Inc. | 2024-01-19 | Traditional | PDF ↗ |
| K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2023-02-23 | Traditional | PDF ↗ |
| K221624 | Avenda Health AI Prostate Cancer Planning Software | Avenda Health, Inc. | 2022-11-22 | Traditional | PDF ↗ |
| K212616 | Koios DS | Koios Medical, Inc. | 2021-12-16 | Traditional | PDF ↗ |
| K202300 | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | Optellum, Ltd. | 2021-03-05 | Traditional | PDF ↗ |
| K201555 | EchoGo Pro | Ultromics, Ltd. | 2020-12-18 | Traditional | PDF ↗ |
| K200760 | Rapid ASPECTS | Ischemaview, Inc. | 2020-06-26 | Traditional | PDF ↗ |
| K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019-07-03 | Traditional | PDF ↗ |
| DEN170022 | QuantX | Quantitative Insights, Inc. | 2017-07-19 | Direct | — |
Product code POK · Class II · Radiology. Data: openFDA.