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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 K143397
Device Name ICIS View
Applicant
Agfa HealthCare N.V.
Septestraat 27
Mortsel,  BE B-2640
Applicant Contact JODI COLEMAN
Correspondent
AGFA Healthcare
10 South Academy Street
Greenville,  SC  29601
Correspondent Contact ShaeAnn Cavanagh
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/26/2014
Decision Date 06/01/2015
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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