FDA 510(k) Applications Submitted by AGFA HEALTHCARE N.V.

FDA 510(k) Number Submission Date Device Name Applicant
K121948 07/03/2012 CR 10-X DIGITIZER AGFA HEALTHCARE N.V.
K121095 04/11/2012 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V.
K122736 09/19/2012 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V.
K090672 03/13/2009 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS AGFA HEALTHCARE N.V.
K092238 07/23/2009 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS AGFA HEALTHCARE N.V.
K092669 08/31/2009 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V.
K170434 02/13/2017 Enterprise Imaging XERO Viewer 8.1 Agfa HealthCare N.V.
K111945 07/08/2011 IMPAX NEXT GENERATION AGFA HEALTHCARE N.V.
K142316 08/19/2014 IMPAX Agility AGFA HEALTHCARE N.V.
K143397 11/26/2014 ICIS View Agfa HealthCare N.V.
K161061 04/15/2016 IMPAX Volume Viewing 4.0 AGFA HEALTHCARE N.V.
K111638 06/13/2011 IMPAX VOLUME VIEWING AGFA HEALTHCARE N.V.
K133135 10/04/2013 IMPAX VOLUME VIEWING 3.0 AGFA HEALTHCARE N.V.
K161368 05/17/2016 DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) Agfa HealthCare N.V.
K152639 09/15/2015 DR 600 AGFA HEALTHCARE N.V.
K111324 05/11/2011 CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER AGFA HEALTHCARE N.V.
K112670 09/14/2011 DX-D 600 AGFA HEALTHCARE N.V.
K103050 10/15/2010 DX-D 300 AGFA HEALTHCARE N.V.
K103597 12/08/2010 DX-D 100 AGFA HEALTHCARE N.V.
K141192 05/08/2014 DR 400 AGFA HEALTHCARE N.V.
K131408 05/15/2013 CR 12-X DIGITIZER AGFA HEALTHCARE N.V.
K141602 06/16/2014 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V.
K142184 08/08/2014 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V.
K132800 09/06/2013 SKINTELL AGFA HEALTHCARE N.V.
K180589 03/06/2018 DR 800 with MUSICA Dynamic Agfa HealthCare N.V.
K172784 09/15/2017 DX-D Imaging Package Agfa HealthCare N.V.


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