Flat panel sensor holder DR-XD 3000 HOLDER2530 E
Flat panel sensor holder DR-XD 3000 HOLDER2530 E is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K212956 on 8 Nov 2021 and listed in FDA GUDID since 28 Dec 2021 (UDI-DI 04547410480641), active as of 23 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 | Number04547410480641 | Date28 Dec 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212956 | Date8 Nov 2021 | StatusActive |
Official records
- AccessGUDID record 04547410480641
- FDA 510(k) database K212956
Across registries
- FDA 510(k) K212956 decided 8 Nov 2021 Active
- FDA GUDID UDI-DI 04547410480641 listed 28 Dec 2021 Listed
Timeline
- Cleared FDA 510(k) K212956
- Listed FDA GUDID 04547410480641
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flat panel sensor holder
- Generic name
- Mobile general-purpose fluoroscopic x-ray system, digital
- Model / reference
- DR-XD 3000 HOLDER2530 E
- Primary DI / UDI-DI
- 04547410480641
- 510(k) Number
- FDA product code
- OWB, JAA
- GMDN term
- Mobile general-purpose fluoroscopic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1650
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Mobile general-purpose fluoroscopic x-ray system, digital.