510(k) K213620 · IYO System, Imaging, Pulsed Echo, Ultrasonic
ATUSA Automated 3D Breast Ultrasound System
| Applicant | Isono Health, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Apr 22, 2022 |
| Received | Nov 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213620
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.