510(k) K173079

Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 by Philips Medical Systems Nederland B.V. — Product Code LNH

K173079 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4". The FDA issued a decision of Substantially Equivalent on Apr 4, 2018. 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.