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510(k) Data Aggregation

    K Number
    K042755
    Device Name
    MONOCHROME LCD MONITOR, RADIFORCE G51
    Manufacturer
    EIZO NANAO CORPORATION
    Date Cleared
    2005-02-10

    (129 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K032026,K033859
    Why did this record match?
    Device Name :

    MONOCHROME LCD MONITOR, RADIFORCE G51

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

    5 Megapixel Monochrome LCD Monitor, RadiForce G51 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 G51 device is a digital image display. Clearance letter (510(k) No. K032026, dated on AUG 27, 2003) had been issued. The device is qualified for various medical image applications including digital mammography system.

    AI/ML Overview

    The provided text does NOT include information about acceptance criteria or a study proving the device meets those criteria. The submission is a 510(k) premarket notification for a medical display monitor (RadiForce G51).

    The core of a 510(k) submission is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove the device meets specific performance acceptance criteria through a clinical study. The provided documents focus on:

    • Device Identification: Naming the device, manufacturer, and official correspondent.
    • Classification: Identifying the regulatory classification and product code.
    • Predicate Device Comparison: Listing the predicate device and comparing the new device's technical specifications to it. This is the primary method used to demonstrate substantial equivalence for this type of device.
    • Intended Use: Stating how the device is meant to be used.
    • FDA Clearance Letter: Confirming that the FDA has reviewed the submission and found the device substantially equivalent.

    Therefore, I cannot populate the table or answer the questions related to acceptance criteria and a study proving device performance because this information is not present in the provided text.

    The document details the device's technical specifications and compares them to a predicate device, but it does not describe any specific performance acceptance criteria or a study designed to evaluate how the device performs against those criteria using a test set, expert readers, or ground truth.

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