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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 22 Results
510(K) Number: K050228
 
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Product Description
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WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs), used in the ... 2 09/11/2008 AGFA Corp.
IMPAX® 4.1, IMPAX ® 4.5, IMPAX ® 5.0, IMPAX ® 5.1 IMPAX ® 5.2, IMPAX ® 6.0, IMPAX ® 6.2; Picture Arc... 2 09/11/2008 AGFA Corp.
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects... 2 11/17/2015 AGFA Healthcare Corp.
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8 2 03/16/2011 AGFA Corp.
IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2 The IM... 2 11/18/2011 AGFA Corp.
IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numb... 2 02/03/2009 AGFA Corp.
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured r... 2 08/10/2012 AGFA Corp.
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interf... 2 06/29/2017 AGFA Healthcare Corp.
IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular informati... 2 11/23/2011 AGFA Corp.
IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a ... 2 02/25/2011 AGFA Corp.
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