510(k) K251355 ยท QHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
X1-FFR
| Applicant | Spectrawave, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Oct 17, 2025 |
| Received | Apr 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251355
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.