510(k) K253181 ยท IZI System, X-Ray, Angiographic
SURGIMAGE SIM 1000H Fluorescence Imaging Platform
| Applicant | Surgimage Corporation, Taipei City, TW |
| Decision | Substantially Equivalent, May 13, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253181
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.