510(k) K071310

SYNGO CT ONCOLOGY SOFTWARE PACKAGE by Siemens AG — Product Code JAK

K071310 is an FDA 510(k) premarket notification submitted by Siemens AG for the device "SYNGO CT ONCOLOGY SOFTWARE PACKAGE". The FDA issued a decision of Substantially Equivalent on June 8, 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 has at least 10 other 510(k) clearances on record.