TRIMAX 3543C Detector DETECTOR, PACKED, TRIMAX, 3543C
TRIMAX 3543C Detector DETECTOR, PACKED, TRIMAX, 3543C (AE4201) is a Class II device made by Carestream Health, Inc., cleared under FDA 510(k) K150766 on 24 Jun 2015 and listed in FDA GUDID since 23 May 2017 (UDI-DI 60889974160192), 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 | Number60889974160192 | Date23 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150766 | Date24 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 60889974160192
- FDA 510(k) database K150766
Across registries
- FDA 510(k) K150766 decided 24 Jun 2015 Active
- FDA GUDID UDI-DI 60889974160192 listed 23 May 2017 Listed
Timeline
- Cleared FDA 510(k) K150766
- Listed FDA GUDID 60889974160192
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TRIMAX 3543C Detector
- Generic name
- Indirect flat panel x-ray detector
- Model / Ref / Catalog
- DETECTOR, PACKED, TRIMAX, 3543C, AE4201
- Primary DI / UDI-DI
- 60889974160192
- 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.