K061855 is an FDA 510(k) clearance for the NEUROQUANT. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Cortechs Labs, Inc. (La Jolla, US). The FDA issued a Cleared decision on August 10, 2006, 41 days after receiving the submission on June 30, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K061855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2006 |
| Decision Date | August 10, 2006 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |