BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RefleXion Medical Radiotherapy System, Reflexion X2

    K Number: K252071 · Decision Dec 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    170

    Basic Information

    Device Name
    RefleXion Medical Radiotherapy System, Reflexion X2
    K Number
    K252071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5060
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reflexion Medical, Inc.
    Date Received
    July 1, 2025
    Decision Date
    December 18, 2025
    Product Code
    QVA
    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
    QVA Fludeoxyglucose F18-Guided Radiation Therapy System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QVA), ordered by most recent decision date.

    RefleXion Medical Radiotherapy System (RMRS)

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Reflexion Medical, Inc.

    K Number Device Name
    DEN220014 RefleXion Medical Radiotherapy System (RMRS)
    K190978 RefleXion Medical Radiotherapy System