Symbia VA10A Family

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 Va10a Family.

Pre-market Notification Details

Device IDK210557
510k NumberK210557
Device Name:Symbia VA10A Family
ClassificationSystem, Tomography, Computed, Emission
Applicant Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
ContactTabitha Estes
CorrespondentTabitha Estes
Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-25
Decision Date2021-05-12

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