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510(k) Data Aggregation

    K Number
    K141536
    Device Name
    VIEWING CLIENT MOBILE
    Manufacturer
    AXON MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    2015-03-06

    (269 days)

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

    AXON MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Viewing Client Mobile is a software application that is intended to be used by qualified medical professionals for the review of medical images derived from multiple modalities. Clinical reports can also be viewed using this device. The Viewing Client Mobile application can be used to perform image manipulation (for example, window width and level, zoom, pan, rotation) and measurement. It can display both lossless and lossy compressed images. For lossy images, the user must determine if the level of loss is acceptable for their purposes. The Viewing Client Mobile application provides wireless and portable access to medical images from only the following modalities: MRI, CT, X-ray and Ultrasound. It is not intended to replace a full workstation and should be used only when there is no access to one. The Viewing Client Mobile application must not be used for the primary interpretation of mammographic images.
    Device Description
    AXON Medical Technology Corp.'s Viewing Client Mobile is a viewer that facilitates the secure viewing of 2D, DICOM 3.0-compliant soft-copy imaging studies both within and without the Enterprise context. The product operates through an API. Viewing Client Mobile is used under mobile viewing conditions within the device's intended use. Viewing Client Mobile app runs on iOS platforms. Core measurement and image manipulation tools provided by the Viewing Client Mobile include zoom, pan, invert, W/L, Pixel Value/ Line/ Angle, ROI and CINE. The Viewing Client Mobile also supports multiseries and study display. The Viewing Client Mobile app operates on the iPad, a portable, "off-the-sheh" hardware device, used to wirelessly access medical images under mobile conditions, and is therefore more sensitive to factors not typical for reading room workstations (e.g. display condition, variable lighting, viewing angle, etc.). The user is therefore instructed to properly follow the operating instructions provided with the hardware device, utilize the Viewing Client Mobile's risk mitigation features and heed precautions related to safe device use.
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