NEUROQUANT

System, Image Processing, Radiological

CORTECHS LABS, INC

The following data is part of a premarket notification filed by Cortechs Labs, Inc with the FDA for Neuroquant.

Pre-market Notification Details

• Device ID: K061855
• 510k Number: K061855
• Device Name: NEUROQUANT
• Classification: System, Image Processing, Radiological
• Applicant: CORTECHS LABS, INC 1020 PROSPECT ST., SUITE 304 La Jolla, CA
• Contact: Allan Green
• Correspondent: Allan Green; CORTECHS LABS, INC 1020 PROSPECT ST., SUITE 304 La Jolla, CA
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-30
• Decision Date: 2006-08-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00863725000317	K061855	000
00863725000300	K061855	000