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Agfa Healthcare N.V.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories3
Latest FDA decision2025-10-15
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