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510(k) Data Aggregation

    K Number
    K093478
    Device Name
    KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM
    Manufacturer
    TROPHY
    Date Cleared
    2010-04-26

    (168 days)

    Product Code
    MUH
    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 Kodak RVG 6500 wireless digital intraoral system is intended to replace dental Xray film for any intraoral diagnostic purposes. It uses the wireless technology in order to transmit the acquire image to a computer. It requires additional components such as conventional extraoral X-ray source and visualization software. The Kodak RVG 6500 IPS System, in addition, provides the Intelligent Positioning System (IPS) to enable the dentist prior to acquisition to correctly align the X-ray beam to the RVG sensor.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Kodak RVG 6500 System and Kodak RVG 6500 IPS System. It declares the device substantially equivalent to legally marketed predicate devices.

    The letter itself does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to existing devices and falls under general controls and potentially special controls for Class II devices.

    Therefore, I cannot provide the requested information from the provided text. The document is a regulatory approval, not a performance study report.

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