510(k) K213583

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems by Philips Medical Systems Nederland B.V. — Product Code LNH

K213583 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems". The FDA issued a decision of Substantially Equivalent on May 16, 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.