510(k) K153324

Ingenia 1.5T and Ingenia 1.5T S R5.2 by Philips Medical Systems Nederlands B.V. — Product Code LNH

K153324 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederlands B.V. for the device "Ingenia 1.5T and Ingenia 1.5T S R5.2". The FDA issued a decision of Substantially Equivalent on March 22, 2016. 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.