AI-Rad Companion Brain MR

System, Image Processing, Radiological

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 Ai-rad Companion Brain Mr.

Pre-market Notification Details

Device IDK193290
510k NumberK193290
Device Name:AI-Rad Companion Brain MR
ClassificationSystem, Image Processing, Radiological
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Mail Code 65-3 Malvern,  PA  19355
ContactLauren Bentley
CorrespondentLauren Bentley
Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Mail Code 65-3 Malvern,  PA  19355
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-27
Decision Date2020-06-17

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