510(k) K142734

TRILLIUM Oval MR System by Hitachi Medical Systems America, Inc. — Product Code LNH

K142734 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "TRILLIUM Oval MR System". The FDA issued a decision of Substantially Equivalent on March 2, 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.