BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    LCD Monitor (C1216W, C822W, C821W)

    K Number: K253242 · Decision Oct 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    134
    Applicant Total
    17
    Review Days
    30

    Basic Information

    Device Name
    LCD Monitor (C1216W, C822W, C821W)
    K Number
    K253242
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Beacon Display Technology Co., Ltd.
    Date Received
    September 29, 2025
    Decision Date
    October 29, 2025
    Product Code
    PGY
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PGY Display, Diagnostic Radiology

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    Other Clearances by Shenzhen Beacon Display Technology Co., Ltd.

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    K202374 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
    K201211 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
    K201599 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
    K200864 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
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