510(k) K173637

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis by Siemens Medical Solutions USA, Inc. — Product Code JAK

K173637 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "syngo.CT Coronary Analysis; syngo.CT Vascular Analysis". The FDA issued a decision of Substantially Equivalent on Mar 30, 2018. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Siemens Medical Solutions USA, Inc. has 783 other 510(k) clearances on record.