Syngo.CT Clinical Extensions

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 Syngo.ct Clinical Extensions.

Pre-market Notification Details

Device IDK173625
510k NumberK173625
Device Name:Syngo.CT Clinical Extensions
ClassificationSystem, X-ray, Tomography, Computed
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Malvern,  PA  19355
ContactKimberly Mangum
CorrespondentKimberly Mangum
Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Malvern,  PA  19355
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-24
Decision Date2018-03-08
Summary:summary

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