Green RE 400 Speed 18X43
by Agfa Corp.
Green RE 400 Speed 18X43 (EHYK8) is a Class II device made by Agfa Corp., cleared under FDA 510(k) K023020 on 26 Sep 2002 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05414904040126), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05414904040126 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023020 | Date26 Sep 2002 | StatusActive |
Official records
- AccessGUDID record 05414904040126
- FDA 510(k) database K023020
Across registries
- FDA 510(k) K023020 decided 26 Sep 2002 Active
- FDA GUDID UDI-DI 05414904040126 listed 1 Sep 2016 Listed
Recalls
-
- Terminated Z-1404-05
Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
Timeline
- Cleared FDA 510(k) K023020
- Recall initiated FDA recalls Z-1404-05
- Listed FDA GUDID 05414904040126
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Green RE 400 Speed
- Generic name
- X-ray film cassette, manual
- Model / Ref / Catalog
- Green RE 400 Speed 18X43, EHYK8
- Description
- USABS CAS US GREEN 400 18X43
- Primary DI / UDI-DI
- 05414904040126
- 510(k) Number
- FDA product code
- IXA
- GMDN term
- X-ray film cassette, manual
- Device class
- Class II
- Regulation number
- 892.1850
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 43 CentimeterLength — 18 Centimeter