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510(k) Data Aggregation

    K Number
    K123082
    Device Name
    MOBILECT VIEWER
    Manufacturer
    NEPHOSITY, INC.
    Date Cleared
    2013-05-16

    (227 days)

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

    NEPHOSITY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MobileCT Viewer software program provides for communication and display of CT, MRI, X-ray medical images on the Apple iPad (4th generation, late 2012) . It is intended for use as a diagnostic, review and analysis tool by trained professionals. MobileCT Viewer provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. This device is not to be used for mammography.
    Device Description
    The MobileCT Viewer is a software-based Picture Archiving and Communication System (PACS) used with computing servers and specific mobile devices. DICOM-compliant medical images from CT : MRI, X-ray modalities are stored on the server component. MobileCT Viewer retrieves patent image data securely via a network connection with the server. DICOM files are losslessly compressed for network transfer and downloaded by MobileCT Viewer for display on the mobile device component. Communication and display on the mobile device assist trained professionals in the diagnostic interpretation, review and analysis of the medical images. MobileCT Viewer includes the capability to perform to the displayed image: - · adjust window width and level (i.e. contrast) values, - · apply view transforms (e.g. zoom, pan, and rotation), - · measure distances, and - · display measurement lines and annotations.
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