510(k) K231941 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ARIETTA x10
| Applicant | FUJIFILM Healthcare Americas Corporation, Lexington MA, US |
| Decision | Substantially Equivalent, Nov 20, 2023 |
| Received | Jun 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231941
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.