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510(k) Data Aggregation

    K Number
    K062221
    Device Name
    CXDI-40EC
    Manufacturer
    CANON, INC.
    Date Cleared
    2006-08-17

    (15 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K031447,K050987,K031633
    Why did this record match?
    Device Name :

    CXDI-40EC

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

    DIGITAL RADIOGRAPHY CXDI-40EC 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

    The Canon digital radiography CXDI-40EC is used to directly capture and convert conventional projection Xray 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 describes a 510(k) summary for the Canon CXDI-40EC digital radiography device. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria, specific device performance metrics, or details of a study proving the device meets acceptance criteria in the manner requested (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

    The summary primarily discusses:

    • Device Description: The CXDI-40EC is a digital radiography device for capturing and converting X-ray images. Its key difference from a predicate (CXDI-40EG) is the use of CsI (Cesium Iodide) as the fluorescent screen material, leading to higher X-ray absorption, lower dose requirements, and approximately double the DQE (Detective Quantum Efficiency) compared to the GOS (Gadolinium Oxy Sulfide) used in CXDI-40EG. It is similar to CXDI-40C in sensor characteristics but differs in the control PC interface.
    • Intended Use: Replaces radiographic film/screen systems in all general-purpose diagnostic procedures, excluding mammography.
    • Substantial Equivalence: The submission asserts substantial equivalence based on similar amorphous silicon array specifications, imaging principle, intended use, and design control activities, despite the differences in fluorescent screen material and control PC interface.

    Therefore, I cannot provide the requested information from the given text because it is not present in the document. The document is a regulatory submission focused on substantial equivalence to predicate devices, not a detailed performance study with explicit acceptance criteria and corresponding results.

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