510(k) K083498

PHILIPS MODEL MX 16 SLICE CT SYSTEM by Philips Medical Systems (Cleveland), Inc. — Product Code JAK

K083498 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "PHILIPS MODEL MX 16 SLICE CT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 17, 2008. 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.