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510(k) Data Aggregation

    K Number
    K062054
    Device Name
    5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510
    Manufacturer
    EIZO NANAO CORPORATION
    Date Cleared
    2006-10-06

    (78 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K042755
    Predicate For
    K080422,K112354
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    RadiForce GS510 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.

    Device Description

    RadiForce GS510 device is a digital image display. G51 displays high-definition (5 Megapixel) medical imaging.

    AI/ML Overview

    I am sorry, but the provided text only contains a 510(k) summary and FDA clearance letter for a medical display monitor (RadiForce GS510). It does not contain any information about a study that assesses the performance of a device against acceptance criteria, nor does it describe acceptance criteria for such a study.

    The document discusses the device's technical specifications and its substantial equivalence to a predicate device, focusing on its use in medical imaging applications. It does not mention any clinical trials, performance studies with human readers, or the establishment of ground truth by experts. Therefore, I cannot extract the requested information.

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