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510(k) Data Aggregation

    K Number
    K983739
    Device Name
    OPTUM, INTRAORAL CAMERA SYSTEM
    Manufacturer
    CAMSIGHT, INC.
    Date Cleared
    1999-01-19

    (89 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intraoral camera system, Optum, of Camsight, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the Optum Intraoral Camera System, indicating that the device has been found substantially equivalent to legally marketed predicate devices. This type of regulatory document typically does not contain detailed information about acceptance criteria, specific performance studies, or technical validation data as would be found in a clinical study report or a more comprehensive technical submission.

    The letter confirms the device's indications for use and its classification but does not delve into the depth of information requested in your prompt regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore,Based on the provided text, the requested information cannot be extracted. The document is a regulatory clearance letter and does not include details on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodology.

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