510(k) K163331

Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist by Ge Medical Systems, LLC — Product Code LNH

K163331 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist". The FDA issued a decision of Substantially Equivalent on Mar 17, 2017. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ge Medical Systems, LLC has 328 other 510(k) clearances on record.