510(k) K190461

Achieva 1.5T, 3.0T and Intera 1.5T MR Systems by Philips Medical Systems Nederland B.V. — Product Code LNH

K190461 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Achieva 1.5T, 3.0T and Intera 1.5T MR Systems". The FDA issued a decision of Substantially Equivalent on Jun 4, 2019. 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.