AV Cardiac CT

About This 510(k) Submission

K260169 is an FDA 510(k) clearance for the AV Cardiac CT, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on March 5, 2026, 44 days after receiving the submission on January 20, 2026. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.