510(k) K061916

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

K061916 is an FDA 510(k) premarket notification submitted by Imris, Inc. for the device "NEURO II-SE, MODELS OR-MB-DR AND OR-DR". The FDA issued a decision of Substantially Equivalent on August 11, 2006. 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.