Uc-5000
Uc-5000 (900117) is a Class II device made by Source-Ray, Inc., cleared under FDA 510(k) K163063 on 12 Dec 2016 and listed in FDA GUDID since 30 Jan 2017 (UDI-DI 00867538000304), active as of 21 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 | Number00867538000304 | Date30 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163063 | Date12 Dec 2016 | StatusActive |
Official records
- AccessGUDID record 00867538000304
- FDA 510(k) database K163063
Across registries
- FDA 510(k) K163063 decided 12 Dec 2016 Active
- FDA GUDID UDI-DI 00867538000304 listed 30 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K163063
- Listed FDA GUDID 00867538000304
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Mobile basic diagnostic x-ray system, digital
- Model / Ref / Catalog
- UC-5000, 900117
- Primary DI / UDI-DI
- 00867538000304
- 510(k) Number
- FDA product code
- IZL
- GMDN term
- Mobile basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1720
- GUDID distribution status
- In Commercial Distribution
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