510(k) K251805

syngo.CT Dual Energy by Siemens Medical Solutions USA, Inc. — Product Code JAK

K251805 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "syngo.CT Dual Energy". The FDA issued a decision of Substantially Equivalent on October 15, 2025. 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 at least 10 other 510(k) clearances on record.