510(k) K232346

Digital Expert Access with Remote Scanning by GE Healthcare — Product Code LNH

K232346 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "Digital Expert Access with Remote Scanning". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. GE Healthcare has at least 10 other 510(k) clearances on record.