510(k) K113511

ECHOSTAR SPICA 1.5T MR SYSTEM by Alltech Medical Systems America, Inc. — Product Code LNH

K113511 is an FDA 510(k) premarket notification submitted by Alltech Medical Systems America, Inc. for the device "ECHOSTAR SPICA 1.5T MR SYSTEM". The FDA issued a decision of Substantially Equivalent on May 2, 2012. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Alltech Medical Systems America, Inc. has at least 3 other 510(k) clearances on record.