BRIT Lite 3.4.2
by Brit Systems
BRIT Lite 3.4.2 is a Class II device made by Brit Systems, cleared under FDA 510(k) K081168 on 23 Mar 2009 and listed in FDA GUDID since 30 Aug 2021 (UDI-DI 00850631008360), 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 | Number00850631008360 | Date30 Aug 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081168 | Date23 Mar 2009 | StatusActive |
Official records
- AccessGUDID record 00850631008360
- FDA 510(k) database K081168
Across registries
- FDA 510(k) K081168 decided 23 Mar 2009 Active
- FDA GUDID UDI-DI 00850631008360 listed 30 Aug 2021 Listed
Timeline
- Cleared FDA 510(k) K081168
- Listed FDA GUDID 00850631008360
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BRIT Lite
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 3.4.2
- Primary DI / UDI-DI
- 00850631008360
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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