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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K212528
Device Name Change Healthcare Cardiology
Applicant
Change Healthcare Israel , Ltd.
26 Harokmim St.
Holon,  IL 5885849
Applicant Contact Chester McCoy
Correspondent
Change Healthcare Canada Company
10711 Cambie Rd.
Richmond,  CA V6X3G5
Correspondent Contact Chester McCoy
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/11/2021
Decision Date 10/18/2021
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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