NAEOTOM Alpha, 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 Naeotom Alpha, Scan&go.

Pre-market Notification Details

Device IDK211591
510k NumberK211591
Device Name:NAEOTOM Alpha, Scan&GO
ClassificationSystem, X-ray, Tomography, Computed
Applicant Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
ContactTabitha Estes
CorrespondentTabitha Estes
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 Received2021-05-24
Decision Date2021-09-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869263168 K211591 000

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