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    K Number
    K992385
    Device Name
    ORTHOPANTOMOGRAPH OP100D
    Manufacturer
    INSTRUMENTARIUM CORP.
    Date Cleared
    1999-09-28

    (74 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ORTHOPANTOMOGRAPH OP100D

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

    Orthopantomograph® OP100D is intended to be used for producing diagnostic x-ray radiographs of dentition, TM-joints and other oral structures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain detailed information regarding the acceptance criteria of device performance, the study design, or the specific metrics used to demonstrate the device meets those criteria. The document is an FDA 510(k) clearance letter for the Orthopantomograph® OP100D, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

    The document primarily states that the device is intended for "producing diagnostic x-ray radiographs of dentition, TM-joints and other oral structures" and has received regulatory clearance based on substantial equivalence. This type of regulatory document does not typically include the technical details of performance studies as specific as those requested in your prompt.

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