FEops HEARTguide Simulation Application is an AI-enabled medical device from Feops NV, listed by FDA (510(k), K250635) with a decision date of 2025-11-25. Review panel: Cardiovascular.
| FDA submission number | K250635 |
|---|---|
| Pathway | 510(k) |
| Company | Feops NV |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-11-25 |
| Decision | Substantially Equivalent |
| Product code | QQI |
| Classification | Interventional Cardiovascular Implant Simulation Software Device |
| Device class | 2 |
| Regulation number | 870.1405 |
| Review time (calendar days) | 267 |
| Applicant country | BE |
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.