510(k) K260161 ยท ITX Transducer, Ultrasonic, Diagnostic
SmartGuide Disposable Guides and Grids
| Applicant | UC-CARE , Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Jul 30, 2026 |
| Received | Jan 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260161
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.