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510(k) Data Aggregation

    K Number
    K060961
    Device Name
    15-INCH (38CM) COLOR LCD MONITOR CDL1566A
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2006-05-01

    (24 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K051403
    Predicate For
    K080952
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    15-inch (38cm) Color LCD Monitor CDL1566A is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

    Device Description

    CDL1566A is a 15-inch high definition color medical imaging LCD monitor with high luminance (350cd/m² (typ.)) and high contrast screen (700:1 contrast ratio). Color LCD Monitor CDL1566A is to be used with FUJINON endoscope system, and is manufactured exclusive for FUJINON.

    AI/ML Overview

    I am sorry, but the provided text describes a 510(k) summary for a medical display monitor (TOTOKU ELECTRIC CO., LTD. 15-inch (38cm) Color LCD Monitor CDL1566A), not an AI device.

    Therefore, it does not contain information about:

    • Acceptance criteria and reported device performance related to an algorithm's diagnostic accuracy.
    • Sample sizes for test or training sets, data provenance, or the number/qualifications of experts.
    • Adjudication methods, MRMC studies, standalone algorithm performance, or types of ground truth for an AI model.

    The document focuses on the device's technical specifications (luminance, contrast, size), its intended use as a display for medical images (excluding mammography), and its substantial equivalence to a predicate device based on hardware characteristics.

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