NeuroQuant NQ
NeuroQuant NQ is a Class II device made by Cortechs Labs Inc, cleared under FDA 510(k) K170981 on 7 Sep 2017 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00863725000300), 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 | FDA 510(k)SESE | NumberK170981 | Date7 Sep 2017 | StatusActive |
| United States | GUDID listing | Number00863725000300 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00863725000300
- FDA 510(k) database K170981
- FDA 510(k) database K061855
Across registries
- FDA 510(k) K170981 decided 7 Sep 2017 Active
- FDA GUDID UDI-DI 00863725000300 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K061855
- Listed FDA GUDID 00863725000300
- Cleared FDA 510(k) K170981
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NeuroQuant
- Generic name
- MRI system application software
- Model / reference
- NQ
- Primary DI / UDI-DI
- 00863725000300
- 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.