510(k) K173356

Ingenia Elition S and Ingenia Elition X R5.4 by Philips Medical Systems Nederland B.V. — Product Code LNH

K173356 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Ingenia Elition S and Ingenia Elition X R5.4". The FDA issued a decision of Substantially Equivalent on Mar 6, 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.