510(k) K091195

PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 by Philips Medical Systems (Cleveland), Inc. — Product Code JAK

K091195 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511". The FDA issued a decision of Substantially Equivalent on May 27, 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.