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Agfa Healthcare N.V.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K252199 AGFA HealthCare Enterprise ImagingLLZ2025-10-15 View
510(k) K180589 DR 800 with MUSICA DynamicJAA2018-04-05 View
510(k) K172784 DX-D Imaging PackageMQB2017-10-13 View
510(k) K170434 Enterprise Imaging XERO Viewer 8.1LLZ2017-07-03 View
510(k) K161368 DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)MQB2016-09-22 View
510(k) K161061 IMPAX Volume Viewing 4.0LLZ2016-06-22 View
510(k) K131408 CR 12-X DIGITIZERMQB2013-08-29 View
510(k) K122736 DX-D IMAGING PACKAGEMQB2013-03-11 View
510(k) K121095 DX-D IMAGING PACKAGEMQB2012-08-16 View
510(k) K121948 CR 10-X DIGITIZERMQB2012-07-20 View
510(k) K111324 CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZERMUE2011-12-22 View
510(k) K112670 DX-D 600KPR2011-10-27 View
510(k) K111945 IMPAX NEXT GENERATIONLLZ2011-08-05 View
510(k) K111638 IMPAX VOLUME VIEWINGLLZ2011-06-24 View
510(k) K103597 DX-D 100IZL2011-01-03 View
510(k) K103050 DX-D 300KPR2010-10-29 View
510(k) K092669 DX-D IMAGING PACKAGEMQB2009-11-06 View
510(k) K092238 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERSMQB2009-08-11 View
510(k) K090672 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONSMQB2009-05-18 View
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