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510(k) Data Aggregation

    K Number
    K023346
    Device Name
    TROPHYPAN
    Manufacturer
    TROPHY RADIOLOGIE
    Date Cleared
    2003-01-03

    (88 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K012514
    Why did this record match?
    Reference Devices :

    K012514

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

    The TROPHYPAN Panoramic Dental X-Ray System is to be used as an external source of X-ray for imaging of the dento-maxillo-facial area and provides digital radiographic images only through the built-in DIGIPAN ( K012514), digital imaging system.

    Device Description

    TROPHYPAN Panoramic Dental X-Ray System

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the TrophyPan Panoramic Dental X-Ray System. It does not contain the acceptance criteria or a study proving the device meets those criteria. Instead, it states that the device is substantially equivalent to a legally marketed predicate device for its indicated use.

    Therefore, I cannot provide the requested information based on this document. The document primarily focuses on regulatory approval and classification rather than detailed performance study results.

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