510(k) K133692

IMRI 1.5T AND IMRI 3T S by Imris, Inc. — Product Code LNH

K133692 is an FDA 510(k) premarket notification submitted by Imris, Inc. for the device "IMRI 1.5T AND IMRI 3T S". The FDA issued a decision of Substantially Equivalent on February 10, 2014. 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.