510(k) K203216

The Multimodality Advanced Vessel Analysis by Philips Medical Systems Nederland B.V. — Product Code JAK

K203216 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "The Multimodality Advanced Vessel Analysis". The FDA issued a decision of Substantially Equivalent on Nov 25, 2020. 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 106 other 510(k) clearances on record.