SOMATOM Go.Platform Scanners - SOMATOM Go.Now, Go.Up, Go.All, Go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite And SOMATOM X.ceed, Scan&GO Software

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 Scanners - Somatom Go.now, Go.up, Go.all, Go.top, Somatom X. Platform Scanners - Somatom X.cite And Somatom X.ceed, Scan&go Software.

Pre-market Notification Details

Device IDK211373
510k NumberK211373
Device Name:SOMATOM Go.Platform Scanners - SOMATOM Go.Now, Go.Up, Go.All, Go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite And SOMATOM X.ceed, Scan&GO Software
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-04
Decision Date2021-08-27

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