Biograph MMR With Syngo MR E11P-AP01 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-ap01 System Software.

Pre-market Notification Details

Device IDK200213
510k NumberK200213
Device Name:Biograph MMR With Syngo MR E11P-AP01 System Software
ClassificationTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Applicant Siemens Medical Solutions, USA, Inc. 40 Liberty Boulevard Mailcode 65-1A Malvern,  PA  19355
ContactCordell L. Fields
CorrespondentCordell L. Fields
Siemens Medical Solutions, USA, Inc. 40 Liberty Boulevard Mailcode 65-1A 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 Received2020-01-28
Decision Date2020-05-11

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