BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Seg Pro V3 (RT-300)

    K Number: K251306 · Decision Jan 28, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    45
    Applicant Total
    15
    Review Days
    275

    Basic Information

    Device Name
    Seg Pro V3 (RT-300)
    K Number
    K251306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ever Fortune.Ai, Co., Ltd.
    Date Received
    April 28, 2025
    Decision Date
    January 28, 2026
    Product Code
    QKB
    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
    QKB Radiological Image Processing Software For Radiation Therapy

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