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510(k) Data Aggregation

    K Number
    K093240
    Device Name
    BELRAY II
    Manufacturer
    TAKARA BELMONT CORP.
    Date Cleared
    2010-03-22

    (158 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

    The BELRAY II, Model 097 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor.

    Device Description

    extraoral source dental radiographic x-ray unit

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental x-ray unit, which outlines its regulatory classification, indications for use, and compliance requirements. It does not include details about device performance tests, acceptance criteria, study methodologies, or expert reviews as you've requested.

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