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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 K161061
Device Name IMPAX Volume Viewing 4.0
Applicant
AGFA HEALTHCARE N.V.
SEPTESTRAAT 27
MORTSEL,  BE B-2640
Applicant Contact Koen Cobbaert
Correspondent
AGFA HEALTHCARE CORPORATION
10 SOUTH ACADEMY STREET
GREENVILLE,  SC  29601
Correspondent Contact ShaeAnn Cavanagh
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/15/2016
Decision Date 06/22/2016
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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