510(k) K153444

Philips Multislice CT System with Low Dose CT Lung Cancer by Philips Medical Systems (Cleveland), Inc. — Product Code JAK

K153444 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "Philips Multislice CT System with Low Dose CT Lung Cancer". The FDA issued a decision of Substantially Equivalent on April 8, 2016. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Philips Medical Systems (Cleveland), Inc. has at least 10 other 510(k) clearances on record.