510(k) K200515

syngo.CT Cardiac Planning by Siemens Medical Soultions USA, Inc. — Product Code JAK

K200515 is an FDA 510(k) premarket notification submitted by Siemens Medical Soultions USA, Inc. for the device "syngo.CT Cardiac Planning". The FDA issued a decision of Substantially Equivalent on March 25, 2020. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Siemens Medical Soultions USA, Inc. has at least 2 other 510(k) clearances on record.