Syngo Application Software

System, Image Processing, Radiological

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 Application Software.

Pre-market Notification Details

Device IDK170747
510k NumberK170747
Device Name:Syngo Application Software
ClassificationSystem, Image Processing, Radiological
Applicant Siemens Medical Solutions, USA, Inc. 40 Liberty Boulevard 65-1A Malvern,  PA  19355
ContactPatricia D. Jones
CorrespondentPatricia D. Jones
Siemens Medical Solutions, USA, Inc. 40 Liberty Boulevard 65-1A Malvern,  PA  19355
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-10
Decision Date2017-06-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869164311 K170747 000
04056869262567 K170747 000

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