Cleared Traditional

SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse

K250822 · Siemens Medical Solutions USA, Inc. · Radiology

Jul 2025

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K250822 is an FDA 510(k) clearance for the SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on July 3, 2025, 107 days after receiving the submission on March 18, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K250822 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2025
Decision Date	July 03, 2025
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF