510(k) K254021 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Accuro XV
| Applicant | Rivanna Medical, Inc., Charlottesville VA, US |
| Decision | Substantially Equivalent, Apr 9, 2026 |
| Received | Dec 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254021
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.