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510(k) Data Aggregation

    K Number
    K252780

    Validate with FDA (Live)

    Device Name
    LCD Monitor (CL1902A, CL2103F)
    Manufacturer
    Shenzhen Beacon Display Technology Co., Ltd.
    Date Cleared
    2025-12-19

    (108 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    K230684,K180961
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CL1902A and CL2103F are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

    Device Description

    1.3MP LCD Monitor CL1902A is a 19-inch TFT LCD monitor, which is specifically designed to provide the high definition image output for general radiography.

    This product has been strictly calibrated so that it can meet DICOM Part 3.14 and other standards. It uses the latest generation of LED backlight panel, supporting resolution 1280 x 1024. The built-in brightness stabilization control circuit makes sure the brightness of this monitor 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.

    2MP LCD Monitor CL2103F is a 21.3-inch TFT LCD monitor, which is specifically designed to provide the high definition image output for general radiography.

    This product has been strictly calibrated so that it can meet DICOM Part 3.14 and other standards. It uses the latest generation of LED backlight panel, supporting resolution 1600 x 1200. The built-in brightness stabilization control circuit makes sure the brightness of this monitor 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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