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510(k) Data Aggregation

    K Number
    K012355
    Device Name
    IMAGE-X SYSTEM
    Manufacturer
    TG GROUP, INC.
    Date Cleared
    2001-08-09

    (15 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This extraoral source x-ray system is intended for dental radiographic examinations and diagnosis of diseases of the teeth, jaw, and oral structures.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the "Image-x System (Dental x-ray system)" and an "Indication For Use" statement. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.

    Therefore, I cannot provide the requested information based on the input document.

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