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510(k) Data Aggregation

    K Number
    K141061
    Device Name
    REMOTEYE VIEWER
    Manufacturer
    Date Cleared
    2014-08-01

    (99 days)

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

    NEOLOGICA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RemotEye Viewer software product is intended to be used as a fully functional, web-based medical image viewer to download, review, interpret, manipulate, visualize and print medical multi-modality image data in DICOM format, also stored in remote locations with respect to the viewing site. When interpreted by a trained physician, the medical images displayed by RemotEye Viewer can be used as an element for diagnosis. Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.
    Device Description
    The RemotEye Viewer software product is a feature-rich, diagnostic-level, web-based DICOM medical image viewer that allows downloading, reviewing, interpreting, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. The DICOM images may be physically remote with respect to the viewing client, but reachable through a network. Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.
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