Dx-M 5170/200
by Agfa Corp.
Dx-M 5170/200 (E4YW2) is a Class II device made by Agfa Corp., cleared under FDA 510(k) K111324 on 22 Dec 2011 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05414904050385), 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 | Number05414904050385 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111324 | Date22 Dec 2011 | StatusActive |
Official records
- AccessGUDID record 05414904050385
- FDA 510(k) database K111324
Across registries
- FDA 510(k) K111324 decided 22 Dec 2011 Active
- FDA GUDID UDI-DI 05414904050385 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K111324
- Listed FDA GUDID 05414904050385
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dx-M
- Generic name
- Computed radiography digital imaging scanner
- Model / Ref / Catalog
- 5170/200, E4YW2
- Primary DI / UDI-DI
- 05414904050385
- 510(k) Number
- FDA product code
- MUE
- GMDN term
- Computed radiography digital imaging scanner
- Device class
- Class II
- Regulation number
- 892.1715
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Computed radiography digital imaging scanner.