uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite is an AI-enabled medical device from Wuhan United Imaging Healthcare Co.,Ltd, listed by FDA (510(k), K253720) with a decision date of 2026-05-21. Review panel: Radiology.
| FDA submission number | K253720 |
|---|---|
| Pathway | 510(k) |
| Company | Wuhan United Imaging Healthcare Co.,Ltd |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-05-21 |
| Decision | Substantially Equivalent |
| Product code | IYN |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | 2 |
| Regulation number | 892.1550 |
| Review time (calendar days) | 178 |
| Applicant country | CN |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.