510(k) K172878

Vantage Titan 3T, MRT-3010/A7, M-Power GX by Toshiba Medical Systems Corporation, Japan — Product Code LNH

K172878 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems Corporation, Japan for the device "Vantage Titan 3T, MRT-3010/A7, M-Power GX". The FDA issued a decision of Substantially Equivalent on Nov 17, 2017. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Toshiba Medical Systems Corporation, Japan has 8 other 510(k) clearances on record.