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510(k) Data Aggregation

    K Number
    K070122
    Device Name
    MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320
    Manufacturer
    EIZO NANAO CORPORATION
    Date Cleared
    2007-02-08

    (23 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K062053
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    RadiForce GX320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.

    Device Description

    RadiForce GX320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GX320 displays high-definition medical imaging.

    AI/ML Overview

    No information is available regarding acceptance criteria or a study that proves the device meets acceptance criteria in the provided text. The document is a 510(k) summary for a medical display monitor, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and a study to prove they are met.

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