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510(k) Data Aggregation

    K Number
    K140399
    Device Name
    EBM IDO VIEWER
    Manufacturer
    EBM TECHNOLOGIES USA, LLC
    Date Cleared
    2014-09-18

    (212 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    EBM TECHNOLOGIES USA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EBM iDO Viewer software is intended to display images from CT/MR for the trained physician 's diagnosis or referring purpose. EBM iDO Viewer provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography.
    Device Description
    Not Found
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