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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K222360
Device Name AI-Rad Companion (Cardiovascular)
Applicant
Siemens Medical Solutions U.S.A.
40 Liberty Blvd.
Malvern,  PA  19355
Applicant Contact Alexandra Fink
Correspondent
Siemens Medical Solutions U.S.A.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Alexandra Fink
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
QIH  
Date Received08/04/2022
Decision Date 04/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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