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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 K170434
Device Name Enterprise Imaging XERO Viewer 8.1
Applicant
Agfa HealthCare N.V.
Septestraat 27
Mortsel,  BE b-2640
Applicant Contact Jodi Coleman
Correspondent
Agfa HealthCare Corporation
10 South Academy Street
Greenville,  SC  29601
Correspondent Contact ShaeAnn Cavanagh
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/13/2017
Decision Date 07/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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