510(k) K223442

MR 5300 and MR 7700 R11 MR Systems by Philips Medical Systems Nederlands B.V. — Product Code LNH

K223442 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederlands B.V. for the device "MR 5300 and MR 7700 R11 MR Systems". The FDA issued a decision of Substantially Equivalent on December 23, 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 Nederlands B.V. has at least 7 other 510(k) clearances on record.