LesionQuant LQ
LesionQuant LQ is a Class II device made by Cortechs Labs Inc, cleared under FDA 510(k) K061855 on 10 Aug 2006 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00863725000317), 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 | Number00863725000317 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061855 | Date10 Aug 2006 | StatusActive |
Official records
- AccessGUDID record 00863725000317
- FDA 510(k) database K061855
Across registries
- FDA 510(k) K061855 decided 10 Aug 2006 Active
- FDA GUDID UDI-DI 00863725000317 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K061855
- Listed FDA GUDID 00863725000317
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LesionQuant
- Generic name
- MRI system application software
- Model / reference
- LQ
- Primary DI / UDI-DI
- 00863725000317
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- MRI system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under MRI system application software.