510(k) K261037 ยท IZI System, X-Ray, Angiographic
780 nm SPY Portable Handheld Imaging (SPY-PHI) System
| Applicant | Stryker Endoscopy, San Jose CA, US |
| Decision | Substantially Equivalent, May 28, 2026 |
| Received | Mar 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261037
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.