4 results
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45ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
FDA Recall
Terminated
·Agfa Healthcare NV Septestraat 27 Mortsel Belgium·Product code LLZ·August 3, 2018
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)
FDA Recall
Open, Classified
·Agfa Healthcare NV Septestraat 27 Mortsel Belgium·Product code LLZ·September 6, 2024
Agfa HealthCare Enterprise Imaging XERO Viewer
FDA Recall
Open, Classified
·Agfa Healthcare NV Septestraat 27 Mortsel Belgium·Product code LLZ·December 5, 2022
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
FDA Recall
Terminated
·AGFA Healthcare Corp.·Product code MQB·December 21, 2016