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510(k) Data Aggregation

    K Number
    K090623
    Device Name
    DIGITAL RADIOGRAPHY CXDI-40G COMPACT
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    2009-03-24

    (15 days)

    Product Code
    MQB,MOB
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K050987
    Why did this record match?
    Reference Devices :

    K050987

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DIGITAL RADIOGRAPHY CXD1-40G COMPACT provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

    Device Description

    DIGITAL RADIOGRAPHY CXDI-40G COMPACT, designed for easy installation in bucky unit, is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

    AI/ML Overview

    The provided text is a 510(k) summary for the Canon CXDI-40G COMPACT digital radiography device. It describes the device, its intended use, and compares it to a predicate device (Canon CXDI-40EG). However, it does not contain information about acceptance criteria, detailed performance metrics, specific studies conducted, sample sizes for test or training sets, ground truth establishment methods, or expert qualifications.

    The summary primarily focuses on demonstrating substantial equivalence to a predicate device, highlighting changes in physical dimensions and housing for easier installation. It concludes that "The Performance Data demonstrate that CXDI-40G COMPACT is as safe and effective as CXDI-40EG," but it does not present this performance data.

    Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I answer the questions regarding sample sizes, ground truth, experts, or comparative effectiveness studies based on the provided text.

    The available information is limited to:

    • Proposed Device: Canon CXDI-40G COMPACT
    • Predicate Device: Canon CXDI-40EG (K050987)
    • Intended Use: Digital image capture for conventional film/screen radiographic examinations, intended to replace radiographic film/screen systems in all general purpose diagnostic procedures (not for mammography).
    • Comparison: Same intended use, differences in external dimensions and housing for easier installation.
    • Conclusion: Substantially equivalent to predicate based on "Performance Data" and "design control activities and non-clinical testing" (the details of which are not included in this summary).
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