510(k) K122613

VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US by Toshiba America Medical Systems, In.C — Product Code LNH

K122613 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US". The FDA issued a decision of Substantially Equivalent on December 13, 2012. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.