510(k) K233657

NAEOTOM Alpha by Siemens Medical Solutions USA, Inc. — Product Code JAK

K233657 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "NAEOTOM Alpha". The FDA issued a decision of Substantially Equivalent on March 28, 2024. 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.