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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 K120851
Model 1.5
Device Name COMMUNIFY PACS VIEWER
Original Applicant
COMMUNIFY HEALTH, LLC
160w 71st
18 floor
new york,  NY  10023
Original Contact chris relyea
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/21/2012
Decision Date 02/19/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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