510(k) K213516

Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei by Philips Medical Systems Nederland B.V. — Product Code LNH

K213516 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei". The FDA issued a decision of Substantially Equivalent on Mar 3, 2022. 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.