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510(k) Data Aggregation

    K Number
    K031871
    Device Name
    AUTOBONE
    Manufacturer
    GE MEDICAL SYSTEMS EUROPE
    Date Cleared
    2003-06-20

    (3 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE MEDICAL SYSTEMS EUROPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoBone option is a software package that is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data. It runs on Advantage Workstations, revision 4.1 or higher.
    Device Description
    AutoBone is an optional software extension of the Volume Viewer application for Advantage Workstation. This software can be used in order to facilitate visualization of vessel features and assist in segmentation of bony structures.
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