510(k) K162183

Vantage Galan 3T, MRT-3020, V4.0 by Toshibamedical Systems Corporation — Product Code LNH

K162183 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Vantage Galan 3T, MRT-3020, V4.0". The FDA issued a decision of Substantially Equivalent on Nov 25, 2016. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Toshibamedical Systems Corporation has 79 other 510(k) clearances on record.