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

    Diagnostic X-Ray Equipment Model POCT22

    K Number: K252909 · Decision Feb 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    189
    Applicant Total
    2
    Review Days
    144

    Basic Information

    Device Name
    Diagnostic X-Ray Equipment Model POCT22
    K Number
    K252909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ningbo Runyes Medical Instrument Co., Ltd.
    Date Received
    September 12, 2025
    Decision Date
    February 3, 2026
    Product Code
    EHD
    Advisory Committee
    Dental
    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
    EHD Unit, X-Ray, Extraoral With Timer

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