Symbia 6.7

System, Tomography, Computed, Emission

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 Symbia 6.7.

Pre-market Notification Details

Device IDK200474
510k NumberK200474
Device Name:Symbia 6.7
ClassificationSystem, Tomography, Computed, Emission
Applicant Siemens Medical Solutions USA, Inc. 2501 N Barrington Road Hoffman Estates,  IL  60192 -2061
ContactCynthia Busch
CorrespondentCynthia Busch
Siemens Medical Solutions USA, Inc. 2501 N Barrington Road Hoffman Estates,  IL  60192 -2061
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-26
Decision Date2020-03-20

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