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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 K133135
Device Name IMPAX VOLUME VIEWING 3.0
Applicant
AGFA HEALTHCARE N.V.
SEPTESTRAAT 27
MORTSEL,  BE B 2640
Applicant Contact KOEN COBBAERT
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/04/2013
Decision Date 03/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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