BEUDAMED
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    Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

    FDA Enforcement
    Class III ·Ongoing·AGILENT TECHNOLOGIES INC./US·April 19, 2023

    Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

    FDA Recall
    Open, Classified ·AGILENT TECHNOLOGIES INC./US·Product code PQP·February 17, 2023

    Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·February 5, 2013