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
04056869270142 K201477 000
04056869270142 K201477 000
04056869270142 K201477 000
04056869270142 K201477 000
04056869270142 K201477 000
04056869270142 K201477 000
04056869270142 K201477 000
04056869270142 K201477 000
04056869270142 K201477 000
04056869270142 K201477 000
04056869270142 K201477 000
04056869270142 K201477 000

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