Syngo.via View&GO

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.

Pre-market Notification Details

Device IDK201477
510k NumberK201477
Device Name:Syngo.via View&GO
ClassificationSystem, Image Processing, Radiological
Applicant Siemens Healthcare GmbH Siemensstr. 1 Forchheim,  DE 91301
ContactElango Alampalayam Rangappan
CorrespondentElango Alampalayam Rangappan
Siemens Healthcare GmbH Siemensstr. 1 Forchheim,  DE 91301
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-03
Decision Date2020-07-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869270142 K201477 000

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