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510(k) Data Aggregation

    K Number
    K080422
    Date Cleared
    2008-03-10

    (24 days)

    Product Code
    Regulation Number
    892.2050
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    RadiForce GS520 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with performance specified by the manufacture of the system.

    Device Description

    RadiForce GS520 device is a digital image display. G520 displays high-definition (5 Megapixel) medical imaging.

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical monitor and contains no information about acceptance criteria for device performance, a study to prove meeting acceptance criteria, or any of the other requested study design details. The document is primarily focused on regulatory approval based on substantial equivalence to a predicate device, rather than a performance study of a new medical device.

    Therefore, I cannot provide the requested table and information based on the given text.

    The closest relevant information is that the device "complies with the performance specified by the manufacturer of the system" for digital mammography applications, but what that performance is, and how it was verified, is not detailed in this document.

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