EdgeFlow UH10 is an AI-enabled medical device from Edgecare Inc., listed by FDA (510(k), K231677) with a decision date of 2024-03-06. Review panel: Radiology.
| FDA submission number | K231677 |
|---|---|
| Pathway | 510(k) |
| Company | Edgecare Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2024-03-06 |
| Decision | Substantially Equivalent |
| Product code | IYO |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | 2 |
| Regulation number | 892.1560 |
| Review time (calendar days) | 271 |
| Applicant country | KR |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.