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510(k) Data Aggregation

    K Number
    K033466
    Device Name
    COLOR LCD DISPLAY, MODEL RADIFORCE R22
    Manufacturer
    EIZO NANAO CORPORATION
    Date Cleared
    2004-02-20

    (112 days)

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

    COLOR LCD DISPLAY, MODEL RADIFORCE R22

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

    Color LCD Monitor, RadiForce R22 is intended to be used in displaying for diagnosis of Xrray or MRI, etc.

    Device Description

    Color LCD Display, RadiForce R22

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device: "Color LCD Display, RadiForce R22." This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device.

    However, the document does not contain specific information regarding acceptance criteria for device performance, a study proving those criteria, or details such as sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

    The document primarily states the device's intended use: "Color LCD Monitor, RadiForce R22 is intended to be used in displaying for diagnosis of X-ray or MRI, etc." It also lists the regulatory information and general controls applicable to such a device.

    Therefore, I cannot provide the requested table and detailed study information based on the text provided. This kind of information is typically found in the 510(k) submission summary or technical documentation that the FDA reviews, but not in the clearance letter itself.

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