FDA AI Clearance Tracker/K260113
Radiology · 510(k)
uMR Astra
Shanghai United Imaging Healthcare Co., Ltd.
- Device
- uMR Astra
- Company
- Shanghai United Imaging Healthcare Co., Ltd.
- Submission number
- K260113
- Pathway
- 510(k)
- Decision date
- May 22, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- LNH
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.