NEURO II-SE, MODELS OR-MB-DR AND OR-DR

System, Nuclear Magnetic Resonance Imaging

IMRIS, INC.

The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Neuro Ii-se, Models Or-mb-dr And Or-dr.

Pre-market Notification Details

• Device ID: K061916
• 510k Number: K061916
• Device Name: NEURO II-SE, MODELS OR-MB-DR AND OR-DR
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855
• Contact: Thomas M Tsakeris
• Correspondent: Thomas M Tsakeris; IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-06
• Decision Date: 2006-08-11
• Summary: summary