Pxs-710D
Pxs-710D (900100) is a Class II device made by Source-Ray, Inc., cleared under FDA 510(k) K133959 on 22 Jan 2015 and listed in FDA GUDID since 26 Jan 2017 (UDI-DI 00868162000296), active as of 31 May 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 | Number00868162000296 | Date26 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133959 | Date22 Jan 2015 | StatusActive |
Official records
- AccessGUDID record 00868162000296
- FDA 510(k) database K133959
Across registries
- FDA 510(k) K133959 decided 22 Jan 2015 Active
- FDA GUDID UDI-DI 00868162000296 listed 26 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K133959
- Listed FDA GUDID 00868162000296
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Stationary basic diagnostic x-ray system, digital
- Model / Ref / Catalog
- PXS-710D, 900100
- Primary DI / UDI-DI
- 00868162000296
- 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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