4 results
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32ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Enforcement
Class II
·Terminated·Agfa Healthcare NV·October 17, 2018
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
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
FDA Recall
Terminated
·AGFA Healthcare Corp.·Product code MQB·December 21, 2016
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
FDA Enforcement
Class II
·Terminated·AGFA Healthcare Corp.·July 26, 2017