uDR uDR Aurora CX
by Shanghai United Imaging Healthcare Co., Ltd.
uDR uDR Aurora CX is a Class II device made by Shanghai United Imaging Healthcare Co., Ltd., cleared under FDA 510(k) K251167 on 19 Sep 2025 and listed in FDA GUDID since 19 Nov 2025 (UDI-DI 06971576833689), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06971576833689 | Date19 Nov 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK251167 | Date19 Sep 2025 | StatusActive |
Official records
- AccessGUDID record 06971576833689
- FDA 510(k) database K251167
Across registries
- FDA 510(k) K251167 decided 19 Sep 2025 Active
- FDA GUDID UDI-DI 06971576833689 listed 19 Nov 2025 Listed
Timeline
- Cleared FDA 510(k) K251167
- Listed FDA GUDID 06971576833689
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- uDR
- Generic name
- Stationary basic diagnostic x-ray system, digital
- Model / reference
- uDR Aurora CX
- Primary DI / UDI-DI
- 06971576833689
- 510(k) Number
- FDA product code
- KPR
- GMDN term
- Stationary basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
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