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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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