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510(k) Data Aggregation

    K Number
    K032026
    Device Name
    LCD MONITOR, RADIFORCE G11, G31, G51
    Manufacturer
    EIZO NANAO CORPORATION
    Date Cleared
    2003-08-27

    (58 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LCD MONITOR, RADIFORCE G11, G31, G51

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Monochrome LCD Monitor, RadiForce G11, G31 and G51 are intended to be used in displaying for diagnosis of X-ray or MRI, etc.

    Device Description

    46 cm (18.1 inch) Monochrome LCD Monitor, RadiForce G11 53 cm (20.8 inch) Monochrome LCD Monitor, RadiForce G31 54 cm (21.3 inch) Monochrome LCD Monitor, RadiForce G51

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the RadiForce G11, G31, and G51 monochrome LCD monitors for medical imaging. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses the substantial equivalence of these monitors to legally marketed predicate devices and their general indications for use.

    Therefore, I cannot extract the requested information from the provided text.

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