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    K Number
    K152151
    Device Name
    ATAL 9
    Manufacturer
    ATLAIM CORPORATION
    Date Cleared
    2015-11-10

    (99 days)

    Product Code
    MQB, MOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLAIM CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAL 9 is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.
    Device Description
    The ATAL 9 is a digital radiography system, featuring an integrated flat panel digital detector (FPD). ATAL 9 is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the modified panel are the same as our previous panel with a Wi-Fi wireless feature added.
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