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510(k) Data Aggregation

    K Number
    K253242
    Device Name
    LCD Monitor (C1216W, C822W, C821W)
    Manufacturer
    Shenzhen Beacon Display Technology Co., Ltd.
    Date Cleared
    2025-10-29

    (30 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K231026,K172815,K200864
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K231026, K172815, K200864

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

    -- C822W
    This Medical Monitor is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

    -- C1216W
    This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

    -- C821W
    This Medical Monitor is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

    Device Description

    C1216W is 31 inch TFT color LCD monitor, C822W and C821W are 31.5 inch TFT color LCD monitor, they are intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

    These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

    AI/ML Overview

    N/A

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