BEUDAMED
    6 results · 47ms · Sources: EU EUDAMED, US FDA

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    Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.

    FDA Recall
    Terminated ·DICOM GRID INC·Product code LLZ·December 16, 2016

    Intelerad InteleShare software, with ProViewer component

    FDA Recall
    Open, Classified ·DICOM Grid, Inc.·Product code LLZ·November 18, 2025

    Intelerad InteleShare software, with ProViewer component

    FDA Enforcement
    Class II ·Ongoing·DICOM Grid, Inc.·December 24, 2025

    Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.

    FDA Enforcement
    Class II ·Terminated·DICOM GRID INC·January 25, 2017

    Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.

    FDA Recall
    Open, Classified ·DICOM Grid, Inc. d/b/a Ambra Health·Product code LLZ·June 23, 2022

    Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.

    FDA Enforcement
    Class II ·Ongoing·DICOM Grid, Inc. d/b/a Ambra Health·October 5, 2022