QFR (3.0) is an AI-enabled medical device from QFR Solutions bv, listed by FDA (510(k), K243769) with a decision date of 2025-04-04. Review panel: Radiology.
| FDA submission number | K243769 |
|---|---|
| Pathway | 510(k) |
| Company | QFR Solutions bv |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-04-04 |
| Decision | Substantially Equivalent |
| Product code | QHA |
| Classification | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device |
| Device class | 2 |
| Regulation number | 892.1600 |
| Review time (calendar days) | 119 |
| Applicant country | NL |
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.