510(k) K253648

Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades by Philips Medical Systems Nederland B.V. — Product Code LNH

K253648 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades". The FDA issued a decision of Substantially Equivalent on February 23, 2026. 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.