510(k) K082100

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

K082100 is an FDA 510(k) premarket notification submitted by Alltech Medical Systems America, Inc. for the device "ALLTECH ECHOSTAR 1.5 T MR SYSTEM". The FDA issued a decision of Substantially Equivalent on August 6, 2008. 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.