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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated radiological image processing software
510(k) Number K213706
Device Name AI-Rad Companion Brain MR
Applicant
Siemens Healthcare GmBh
40 Liberty Blvd. Mail Code 65-1
Malvern,  PA  19355
Applicant Contact Kira Kuzmenchuk
Correspondent
Siemens Healthcare GmBh
40 Liberty Blvd. Mail Code 65-1
Malvern,  PA  19355
Correspondent Contact Kira Kuzmenchuk
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/24/2021
Decision Date 04/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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