uMR Astra— 510(k) K260113
Substantially EquivalentShanghai United Imaging Healthcare Co., Ltd.
FDA 510(k) clearance K260113 for uMR Astra, Substantially Equivalent on 2026-05-22. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.
Summary
Shanghai United Imaging Healthcare filed the uMR Astra under LNH, nuclear magnetic resonance imaging systems.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
United Imaging filed from Shanghai, China. The decision came 128 calendar days after receipt (January 14 to May 22, 2026).
Clearance details
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code LNH
view allMore clearances from Shanghai United Imaging Healthcare Co., Ltd.
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.