510(k) K132376

DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T by Ge Healthcare (Ge Medical Systems, LLC) — Product Code LNH

K132376 is an FDA 510(k) premarket notification submitted by Ge Healthcare (Ge Medical Systems, LLC) for the device "DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T". The FDA issued a decision of Substantially Equivalent on Nov 15, 2013. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ge Healthcare (Ge Medical Systems, LLC) has 5 other 510(k) clearances on record.