510(k) K250822

SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse by Siemens Medical Solutions USA, Inc. — Product Code JAK

K250822 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse". The FDA issued a decision of Substantially Equivalent on Jul 3, 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.