Dx-D 45C 6007/201
by Agfa Corp.
Dx-D 45C 6007/201 (55DKA) is a Class II device made by Agfa Corp., cleared under FDA 510(k) K142184 on 16 Oct 2014 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05414904197141), 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 | Number05414904197141 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142184 | Date16 Oct 2014 | StatusActive |
Official records
- AccessGUDID record 05414904197141
- FDA 510(k) database K142184
Across registries
- FDA 510(k) K142184 decided 16 Oct 2014 Active
- FDA GUDID UDI-DI 05414904197141 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K142184
- Listed FDA GUDID 05414904197141
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dx-D 45C
- Generic name
- Indirect flat panel x-ray detector
- Model / Ref / Catalog
- 6007/201, 55DKA
- Primary DI / UDI-DI
- 05414904197141
- 510(k) Number
- FDA product code
- MQB
- GMDN term
- Indirect flat panel x-ray detector
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Indirect flat panel x-ray detector.