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

    AccuCheck

    K Number: K250696 · Decision Oct 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    6
    Review Days
    231

    Basic Information

    Device Name
    AccuCheck
    K Number
    K250696
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Manteia Technologies Co., Ltd.
    Date Received
    March 7, 2025
    Decision Date
    October 24, 2025
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

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