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    K Number
    K233119
    Device Name
    8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
    Manufacturer
    Shenzhen Beacon Display Technology Co., Ltd.
    Date Cleared
    2024-12-28

    (458 days)

    Product Code
    PZZ
    Regulation Number
    864.3700
    Type
    Traditional
    Panel
    Pathology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

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

    8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. They are an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. The displays are not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

    Device Description

    The C811WT. PA27T. C811W. PA27 are 8MP Color LCD Displays, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners that have been validated for use with the display.

    The displays are equipped with a 27-inch color LCD panel with a fine pixel pitch. They use the latest generation of LED backlight panels. The built-in brightness stabilization control circuits make sure the brightness of these displays is stable in their life, so the products meet the demands of high precision medical imaging.

    For C811WT. PA27T. C811W. PA27. the only difference is the capacitive touch screen.

    C811WT, PA27T have the same capacitive touch screen. C811W, PA27 don't have a capacitive touch screen.

    The difference between C811WT and PA27T is only different customers which results in the two models. The difference between C811W and PA27 is only different customers which results in the two models.

    AI/ML Overview

    The provided text describes the acceptance criteria and a study proving the device meets these criteria for the Shenzhen Beacon Display Technology Co., Ltd.'s 8MP Color LCD Displays (C811W, C811WT, PA27, PA27T).

    Here's the breakdown of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly derived from the "Test" column, and the reported device performance is presented in the "C811W", "C811WT", "PA27", and "PA27T" columns. The predicate device (Barco MDPC-8127) is also listed for comparison of technological characteristics.

    Acceptance Criteria (Derived from "Test")Reported Device Performance (Example for C811W)
    User Controls (Luminance, White Point, Color Space, Warm-up time)Luminance target, Maximum: 500 cd/m2; Display function: sRGB; White point: D65 (6500K); Color space: sRGB; 30 minutes of warm-up time
    Spatial resolution (MTF at Nyquist frequency)Vertical and Horizontal MTFs are 0.861 and 0.862 at Nyquist frequency
    Pixel defects (count and map)Total number of bright and dark pixels
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