Exprimer EVS 3643G
by Drtech Corp.
Exprimer EVS 3643G is a Class II device made by Drtech Corp., cleared under FDA 510(k) K162552 on 2 Dec 2016 and listed in FDA GUDID since 12 Jan 2017 (UDI-DI 08800018402702), 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 | Number08800018402702 | Date12 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162552 | Date2 Dec 2016 | StatusActive |
Official records
- AccessGUDID record 08800018402702
- FDA 510(k) database K162552
Across registries
- FDA 510(k) K162552 decided 2 Dec 2016 Active
- FDA GUDID UDI-DI 08800018402702 listed 12 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K162552
- Listed FDA GUDID 08800018402702
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Exprimer
- Generic name
- Indirect flat panel x-ray detector
- Model / reference
- EVS 3643G
- Primary DI / UDI-DI
- 08800018402702
- 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.