X1-FFR is an AI-enabled medical device from Spectrawave, Inc., listed by FDA (510(k), K251355) with a decision date of 2025-10-17. Review panel: Radiology.
| FDA submission number | K251355 |
|---|---|
| Pathway | 510(k) |
| Company | Spectrawave, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-10-17 |
| 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) | 170 |
| Applicant country | US |
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.