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510(k) Data Aggregation

    K Number
    K973410
    Device Name
    ULTRACAM
    Manufacturer
    W. EDWARD JOHANSEN
    Date Cleared
    1998-10-08

    (394 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K013690
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intraoral camera system, Ultracam, of Dental Vision Direct, 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

    Ultracam, intraoral camera system and accessories

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Ultracam, intraoral camera system and accessories." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other details requested.

    The letter is a regulatory document granting market clearance and details about the device's intended use, but it does not include the technical study report that would contain the performance evaluation details.

    Therefore, I cannot populate the requested tables and information based on the provided text.

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