Velacur is an AI-enabled medical device from Sonic Incytes, listed by FDA (510(k), K223287) with a decision date of 2023-04-20. Review panel: Radiology.
| FDA submission number | K223287 |
|---|---|
| Pathway | 510(k) |
| Company | Sonic Incytes |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-04-20 |
| Decision | Substantially Equivalent |
| Product code | IYO |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | 2 |
| Regulation number | 892.1560 |
| Review time (calendar days) | 177 |
| Applicant country | CA |
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.