SOMATOM Go Platform – SOMATOM Go.Now, Go.Up, Go.All, Go.Top, Go.Sim, Go.Open Pro, Scan & GO

System, X-ray, Tomography, Computed

Siemens Medical Solutions USA, Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Go Platform – Somatom Go.now, Go.up, Go.all, Go.top, Go.sim, Go.open Pro, Scan & Go.

Pre-market Notification Details

Device IDK192061
501k NumberK192061
Device Name:SOMATOM Go Platform – SOMATOM Go.Now, Go.Up, Go.All, Go.Top, Go.Sim, Go.Open Pro, Scan & GO
ClassificationSystem, X-ray, Tomography, Computed
Applicant Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
ContactAlaine Medio
CorrespondentAlaine Medio
Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-01
Decision Date2019-11-21

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