510(k) K254250

MagicScan-1.5, GreenMR Serenity 1.5T by Xingaoyi Medical Equipment Co.,Ltd — Product Code LNH

K254250 is an FDA 510(k) premarket notification submitted by Xingaoyi Medical Equipment Co.,Ltd for the device "MagicScan-1.5, GreenMR Serenity 1.5T". The FDA issued a decision of Substantially Equivalent on August 17, 2026. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000.