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510(k) Data Aggregation

    K Number
    K021083
    Device Name
    VERACAM
    Manufacturer
    LUMALITE, INC.
    Date Cleared
    2002-08-30

    (149 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 intra-oral camera system, Veracam, of Lumalite, Inc. is used to provide a view of the mouth so that it assists the dellife in describitits dollar procedures which the dentist has performed on him.

    Device Description

    Veracam; Intra-Oral Camera System and Accessories

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Veracam Intra-Oral Camera System and Accessories, stating that the device is substantially equivalent to a legally marketed predicate device.

    It outlines general regulatory requirements, but it does not detail any performance studies, acceptance criteria, or specific metrics of the device's performance. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.

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