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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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Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/... 2 03/31/2008 AGFA Corp.
Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Wester... 2 06/27/2008 AGFA Corp.
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., W... 2 06/27/2008 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.
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 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 CV Results Manager/Results Manager Administration Tool 2 07/29/2010 AGFA Corp.
Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information syst... 2 02/24/2011 AGFA Corp.
IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a ... 2 02/25/2011 AGFA Corp.
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8 2 03/16/2011 AGFA Corp.
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