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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 K181080
Device Name McKesson Cardiology
Applicant
Change Healthcare Israel , Ltd.
Harokmim 26
Holon,  IL 5885849
Applicant Contact Nadia Marchant
Correspondent
Change Healthcare Technologies, LLC
5995 Windward Pkwy.
Alpharetta,  GA  30005
Correspondent Contact Paul Sumner
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/24/2018
Decision Date 05/24/2018
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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