510(k) K083137

NEURO III-SV by Imris, Inc. — Product Code LNH

K083137 is an FDA 510(k) premarket notification submitted by Imris, Inc. for the device "NEURO III-SV". The FDA issued a decision of Substantially Equivalent on December 16, 2008. 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.