510(k) K243335

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR by Canon Medical Systems Corporation — Product Code LNH

K243335 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR". The FDA issued a decision of Substantially Equivalent on January 7, 2025. 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 at least 10 other 510(k) clearances on record.