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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 K210719
Device Name Change Healthcare Anatomical AI
Applicant
Change Healthcare Canada Company
10711 Cambie Road
Richmond,  CA V6X 3GS
Applicant Contact Chester McCoy
Correspondent
Change Healthcare Canada Company
10711 Cambie Road
Richmond,  CA V6X 3GS
Correspondent Contact Chester McCoy
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/10/2021
Decision Date 07/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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