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510(k) Data Aggregation

    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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    K Number
    K113812
    Device Name
    ATAL-8
    Manufacturer
    ATLAIM
    Date Cleared
    2012-05-03

    (132 days)

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

    ATLAIM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAL 8 and ATAL 8c 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 8 and ATAL 8C are flat-panel type digital X-ray detectors that capture radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The ATAL 8 and ATAL 8C device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector Panel is used to capture the image in electronic form. Once the system captures a radiographic image and subsequently displays and stores an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a workstation. The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. The ATAL 8 and ATAL 8C differ only in the enclosure type. They have identical technological characteristics.
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