510(k) K071099

NEURO II-SE, MODELS: OR-DR-OR, OR-MB by Imris, Inc. — Product Code LNH

K071099 is an FDA 510(k) premarket notification submitted by Imris, Inc. for the device "NEURO II-SE, MODELS: OR-DR-OR, OR-MB". The FDA issued a decision of Substantially Equivalent on May 22, 2007. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Imris, Inc. has at least 10 other 510(k) clearances on record.