uWS uWS-MR
by Shanghai United Imaging Healthcare Co., Ltd. 2 variants
uWS uWS-MR is a Class II device made by Shanghai United Imaging Healthcare Co., Ltd., cleared under FDA 510(k) K220332 on 27 Oct 2022 (1 earlier submission) and listed in FDA GUDID since 19 Jun 2022 (UDI-DI 06971576834143), 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 | FDA 510(k)SESE | NumberK220332 | Date27 Oct 2022 | StatusActive |
| United States | GUDID listing | Number06971576834143 | Date19 Jun 2022 | StatusListed |
Official records
- AccessGUDID record 06971576834143
- FDA 510(k) database K220332
- FDA 510(k) database K192601
Across registries
- FDA 510(k) K220332 decided 27 Oct 2022 Active
- FDA GUDID UDI-DI 06971576834143 listed 19 Jun 2022 Listed
Timeline
- Cleared FDA 510(k) K192601
- Listed FDA GUDID 06971576834143
- Cleared FDA 510(k) K220332
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- uWS
- Generic name
- MRI system application software
- Model / reference
- uWS-MR
- Primary DI / UDI-DI
- 06971576834143
- FDA product code
- LLZ, QIH
- GMDN term
- MRI system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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