FDA AI Clearance Tracker/K253720
Radiology · 510(k)
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
Wuhan United Imaging Healthcare Co.,Ltd
- Device
- uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
- Company
- Wuhan United Imaging Healthcare Co.,Ltd
- Submission number
- K253720
- Pathway
- 510(k)
- Decision date
- May 21, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- IYN
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.