Syngo. CT Extended Functionalities

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 Extended Functionalities.

Pre-market Notification Details

Device IDK203699
510k NumberK203699
Device Name:Syngo. CT Extended Functionalities
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 Received2020-12-18
Decision Date2021-04-30

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