510(k) K253720 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
| Applicant | Wuhan United Imaging Healthcare Co.,Ltd, Wuhan, CN |
| Decision | Substantially Equivalent, May 21, 2026 |
| Received | Nov 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253720
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.