Clearance Summary
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite received FDA 510(k) clearance under submission number K253720, sponsored by Wuhan United Imaging Healthcare Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-05-21.
- Submission: K253720
- Applicant / Sponsor: Wuhan United Imaging Healthcare Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2026-05-21
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.