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

    Dental CBCT X-ray System

    K Number: K251642 · Decision Jun 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    4
    Review Days
    29

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    Basic Information

    Device Name
    Dental CBCT X-ray System
    K Number
    K251642
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Yian Medical Technology (Haining) Co., Ltd.
    Date Received
    May 29, 2025
    Decision Date
    June 27, 2025
    Product Code
    OAS
    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
    OAS X-Ray, Tomography, Computed, Dental

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    Other Clearances by Yian Medical Technology (Haining) Co., Ltd.

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