510(k) K151015

ECHELON Oval V 5.0 MRI System by Hitachi Medical Systems America, Inc. — Product Code LNH

K151015 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "ECHELON Oval V 5.0 MRI System". The FDA issued a decision of Substantially Equivalent on July 29, 2015. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Hitachi Medical Systems America, Inc. has at least 10 other 510(k) clearances on record.