The following data is part of a premarket notification filed by Cortechs Labs, Inc with the FDA for Neuroquant.
| Device ID | K170981 |
| 510k Number | K170981 |
| Device Name: | NeuroQuant |
| Classification | System, Image Processing, Radiological |
| Applicant | CorTechs Labs, Inc 4690 Executive Drive, Suite 250 San Diego, CA 92121 |
| Contact | Kora Marinkovic |
| Correspondent | Kora Marinkovic CorTechs Labs, Inc 4690 Executive Drive, Suite 250 San Diego, CA 92121 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-03 |
| Decision Date | 2017-09-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEUROQUANT 77067450 3528099 Live/Registered |
CorTechs Labs, Inc 2006-12-19 |