Fuji Imaging Plate Ip St-55BDK H 1 E
Fuji Imaging Plate Ip St-55BDK H 1 E (47410-05901) is a Class I device made by Fujifilm Corporation, cleared under FDA 510(k) K862414 on 26 Feb 1987 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04547410059014), 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 | Number04547410059014 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK862414 | Date26 Feb 1987 | StatusActive |
Official records
- AccessGUDID record 04547410059014
- FDA 510(k) database K862414
Across registries
- FDA 510(k) K862414 decided 26 Feb 1987 Active
- FDA GUDID UDI-DI 04547410059014 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K862414
- Listed FDA GUDID 04547410059014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fuji Imaging Plate
- Generic name
- Computed radiography digital imaging scanner
- Model / Ref / Catalog
- IP ST-55BDK H 1 E, 47410-05901
- Primary DI / UDI-DI
- 04547410059014
- 510(k) Number
- FDA product code
- EAM
- GMDN term
- Computed radiography digital imaging scanner
- Device class
- Class I
- Regulation number
- 892.1960
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Computed radiography digital imaging scanner.