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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 K232305
Device Name AI-Rad Companion Brain MR
Applicant
Siemens Medical Solutions U.S.A.
40 Liberty Blvd.
Malvern,  PA  19355
Applicant Contact Kira Morales
Correspondent
Siemens Medical Solutions U.S.A.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Kira Morales
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/01/2023
Decision Date 10/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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