510(k) K243227 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
B-Scan
| Applicant | Accutome, Inc. Doing Business AS Keeler USA, Malvern PA, US |
| Decision | Substantially Equivalent, Jul 11, 2025 |
| Received | Oct 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243227
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.