510(k) K092747

PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL by Philips Medical Systems (Cleveland), Inc. — Product Code JAK

K092747 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL". The FDA issued a decision of Substantially Equivalent on October 9, 2009. 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.