BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    AlignRT Plus (8.0)

    K Number: K253012 · Decision Mar 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    8
    Review Days
    180

    Basic Information

    Device Name
    AlignRT Plus (8.0)
    K Number
    K253012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vision Rt, Ltd.
    Date Received
    September 19, 2025
    Decision Date
    March 18, 2026
    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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