510(k) K212673

MR 5300 by Philips Medical Systems Nederland B.V. — Product Code LNH

K212673 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "MR 5300". The FDA issued a decision of Substantially Equivalent on Nov 19, 2021. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Philips Medical Systems Nederland B.V. has 106 other 510(k) clearances on record.