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

    S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

    K Number: K250986 · Decision Sep 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    91
    Applicant Total
    2
    Review Days
    165

    Basic Information

    Device Name
    S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
    K Number
    K250986
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mevion Medical Systems, Inc.
    Date Received
    March 31, 2025
    Decision Date
    September 12, 2025
    Product Code
    LHN
    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
    LHN System, Radiation Therapy, Charged-Particle, Medical

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