Syngo.via View&GO (Version VA10A)

System, Image Processing, Radiological

Siemens Healthcare GmbH

The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo.via View&go (version Va10a).

Pre-market Notification Details

Device IDK182208
510k NumberK182208
Device Name:Syngo.via View&GO (Version VA10A)
ClassificationSystem, Image Processing, Radiological
Applicant Siemens Healthcare GmbH Siemensstr. 1 Forchheim,  DE 91301
ContactElango Alampalayam Rangappan
CorrespondentAlexander Schapovalov
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-08-15
Decision Date2018-09-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869153315 K182208 000

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