AI-Rad Companion Brain MR

Automated Radiological Image Processing Software

Siemens Healthcare GmBh

The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Ai-rad Companion Brain Mr.

Pre-market Notification Details

Device IDK213706
510k NumberK213706
Device Name:AI-Rad Companion Brain MR
ClassificationAutomated Radiological Image Processing Software
Applicant Siemens Healthcare GmBh 40 Liberty Blvd. Mail Code 65-1 Malvern,  PA  19355
ContactKira Kuzmenchuk
CorrespondentKira Kuzmenchuk
Siemens Healthcare GmBh 40 Liberty Blvd. Mail Code 65-1 Malvern,  PA  19355
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-24
Decision Date2022-04-15

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