510(k) K251602 ยท OWB Interventional Fluoroscopic X-Ray System
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Oct 10, 2025 |
| Received | May 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251602
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.