510(k) K163289

syngo. CT Single Source Dual Energy (twin beam) by Siemens Medical Solutions USA, Inc., Ultrasound DI — Product Code JAK

K163289 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI for the device "syngo. CT Single Source Dual Energy (twin beam)". The FDA issued a decision of Substantially Equivalent on Feb 9, 2017. 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., Ultrasound DI has 10 other 510(k) clearances on record.