Novasight Hybrid System is an AI-enabled medical device from Conavi Medical, Inc., listed by FDA (510(k), K252945) with a decision date of 2026-04-17. Review panel: Cardiovascular.
| FDA submission number | K252945 |
|---|---|
| Pathway | 510(k) |
| Company | Conavi Medical, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2026-04-17 |
| Decision | Substantially Equivalent |
| Product code | OBJ |
| Classification | Catheter, Ultrasound, Intravascular |
| Device class | 2 |
| Regulation number | 870.1200 |
| Review time (calendar days) | 214 |
| Applicant country | CA |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.