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510(k) Data Aggregation

    K Number
    K013271
    Device Name
    DXS DIGITAL X-RAY SYSTEM
    Manufacturer
    DOUGLAS C. YOON, DDS
    Date Cleared
    2001-12-13

    (73 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K033147
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An extraoral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

    Device Description

    An extraoral source x-ray system which is a host PC powered device that produces digital radiographs.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification approval letter for a digital dental X-ray system. It does not contain any information about acceptance criteria, study details, performance metrics, ground truth, or sample sizes.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given input.

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