Biograph MMR With Syngo MR E11P System Software

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

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 Biograph Mmr With Syngo Mr E11p System Software.

Pre-market Notification Details

Device IDK163234
510k NumberK163234
Device Name:Biograph MMR With Syngo MR E11P System Software
ClassificationTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Applicant Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway Malvern,  PA  19355
ContactCordell L. Fields
CorrespondentCordell L. Fields
Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway Malvern,  PA  19355
Product CodeOUO  
Subsequent Product CodeKPS
Subsequent Product CodeLNH
Subsequent Product CodeLNI
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-17
Decision Date2017-02-28
Summary:summary

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