Symbia 6.5

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 6.5.

Pre-market Notification Details

Device IDK162337
510k NumberK162337
Device Name:Symbia 6.5
ClassificationSystem, Tomography, Computed, Emission
Applicant SIEMENS MEDICAL SOLUTIONS, USA, INC 2501 N. BARRINGTON ROAD Hoffman Estates,  IL  60192
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-22
Decision Date2016-09-08
Summary:summary

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