510(k) K250959 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
BioticsAI
| Applicant | Bioticsai, Inc., Brentwood CA, US |
| Decision | Substantially Equivalent, Dec 22, 2025 |
| Received | Mar 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250959
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.