MI View&GO

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 Mi View&go.

Pre-market Notification Details

Device IDK201202
510k NumberK201202
Device Name:MI View&GO
ClassificationSystem, Image Processing, Radiological
Applicant Siemens Medical Solutions USA, Inc. 2501 N Barrington Road Hoffman Estates,  IL  60192
ContactClayton Ginn
CorrespondentClayton Ginn
Siemens Medical Solutions USA, Inc. 2501 N Barrington Road Hoffman Estates,  IL  60192
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-04
Decision Date2020-06-02

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