510(k) K230511 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
K3900 Ultrasound Imaging System
| Applicant | Maui Imaging, Bellevue WA, US |
| Decision | Substantially Equivalent, Oct 25, 2023 |
| Received | Feb 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230511
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.