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510(k) Data Aggregation

    K Number
    K120975
    Device Name
    CS 8100 CS 8100 ACCESS
    Manufacturer
    TROPHY
    Date Cleared
    2012-06-22

    (81 days)

    Product Code
    MUH
    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

    The CS 8100 Access and CS 8100 are intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.

    In addition, the CS 8100 is provided with a radiological exam option which allows the display of one determined segment of the dental structures using the capability of the system to explore each slice acquired during an exam.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a dental X-ray system, not a study report. It states that the device is substantially equivalent to a predicate and confirms regulatory compliance. Therefore, the requested information about acceptance criteria, study details, and performance metrics is not available within this document.

    The document discusses the regulatory approval process and general controls but does not contain a scientific study of the device's performance or its acceptance criteria from such a study.

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