THALES Pixium 3543EZ
THALES Pixium 3543EZ is an indirect flat panel x-ray detector (FDA Class II; FDA product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager)) made by General Medical Merate SpA, cleared under FDA 510(k) K213081 on 26 Oct 2021 and listed in FDA GUDID since 10 Feb 2019 (UDI-DI 08054890480154), 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 | FDA 510(k)SESE | NumberK213081 | Date26 Oct 2021 | StatusActive |
| United States | GUDID listing | Number08054890480154 | Date10 Feb 2019 | StatusListed |
Official records
- AccessGUDID record 08054890480154
- FDA 510(k) database K213081
Across registries
- FDA 510(k) K213081 decided 26 Oct 2021 Active
- FDA GUDID UDI-DI 08054890480154 listed 10 Feb 2019 Listed
Timeline
- Listed FDA GUDID 08054890480154
- Cleared FDA 510(k) K213081
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Thales
- Generic name
- Indirect flat panel x-ray detector
- Model / reference
- Pixium 3543EZ
- Primary DI / UDI-DI
- 08054890480154
- 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.