MatriXX FFF E3030015
MatriXX FFF E3030015 is a Class II device made by IBA Dosimetry GmbH, cleared under FDA 510(k) K031634 on 29 Aug 2003 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI EIBAE30300150), active as of 22 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 | NumberEIBAE30300150 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031634 | Date29 Aug 2003 | StatusActive |
Official records
- FDA 510(k) database K031634
Across registries
- FDA 510(k) K031634 decided 29 Aug 2003 Active
- FDA GUDID UDI-DI EIBAE30300150 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K031634
- Listed FDA GUDID EIBAE30300150
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MatriXX FFF
- Generic name
- Accelerator system quality assurance device
- Model / reference
- E3030015
- Primary DI / UDI-DI
- EIBAE30300150
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Accelerator system quality assurance device
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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