510(k) K160152

Trillium Oval V 5.1 MRI System by Hitachi Medical Systems America, Inc. — Product Code LNH

K160152 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "Trillium Oval V 5.1 MRI System". The FDA issued a decision of Substantially Equivalent on May 20, 2016. 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.