SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed

Siemens Medical Solutions USA, Inc. · K233650 · 2024-03-26

SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed is an AI-enabled medical device from Siemens Medical Solutions USA, Inc., listed by FDA (510(k), K233650) with a decision date of 2024-03-26. Review panel: Radiology.

FDA submission numberK233650
Pathway510(k)
CompanySiemens Medical Solutions USA, Inc.
Review panel (specialty)Radiology
FDA decision date2024-03-26
DecisionSubstantially Equivalent
Product codeJAK
ClassificationSystem, X-Ray, Tomography, Computed
Device class2
Regulation number892.1750
Review time (calendar days)133
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.