510(k) K223875

MOBINEURO Alita Intraoperative MRI System by Sino Canada Health Engineering Research Institute (Hefei) — Product Code LNH

K223875 is an FDA 510(k) premarket notification submitted by Sino Canada Health Engineering Research Institute (Hefei) for the device "MOBINEURO Alita Intraoperative MRI System". The FDA issued a decision of Substantially Equivalent on Mar 20, 2023. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000.