510(k) K193097

Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR by Canon Medical Systems Corporation — Product Code LNH

K193097 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR". The FDA issued a decision of Substantially Equivalent on Jul 14, 2020. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Canon Medical Systems Corporation has 96 other 510(k) clearances on record.