510(k) K260169

AV Cardiac CT by Philips Medical Systems Nederland B.V. — Product Code JAK

K260169 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "AV Cardiac CT". The FDA issued a decision of Substantially Equivalent on March 5, 2026. 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 Nederland B.V. has at least 10 other 510(k) clearances on record.