Expd 4357
by Drtech Corp.
Expd 4357 is a Class II device made by Drtech Corp., cleared under FDA 510(k) K231959 on 1 Aug 2023 and listed in FDA GUDID since 4 Sep 2023 (UDI-DI 08800018407905), active as of 21 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 | Number08800018407905 | Date4 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231959 | Date1 Aug 2023 | StatusActive |
Official records
- AccessGUDID record 08800018407905
- FDA 510(k) database K231959
Across registries
- FDA 510(k) K231959 decided 1 Aug 2023 Active
- FDA GUDID UDI-DI 08800018407905 listed 4 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K231959
- Listed FDA GUDID 08800018407905
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Indirect flat panel x-ray detector
- Model / reference
- EXPD 4357
- Primary DI / UDI-DI
- 08800018407905
- 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.