510(k) K063762

SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY by Siemens AG Medical Solutions — Product Code JAK

K063762 is an FDA 510(k) premarket notification submitted by Siemens AG Medical Solutions for the device "SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY". The FDA issued a decision of Substantially Equivalent on January 5, 2007. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Siemens AG Medical Solutions has at least 10 other 510(k) clearances on record.