510(k) K232030

Ingenia Elition R5.7.1 SP4 MR Systems by Philips Medical Systems Nederland B.V. — Product Code LNH

K232030 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Ingenia Elition R5.7.1 SP4 MR Systems". The FDA issued a decision of Substantially Equivalent on August 2, 2023. 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 at least 10 other 510(k) clearances on record.