BEUDAMED
    Product Code: IWM FDA class 2 21 CFR 892.5050

    Synchrotron, Medical

    Radiology

    A medical synchrotron is a type of cyclic particle accelerator used in advanced medical facilities to generate high-energy particle beams, primarily for use in precision radiation therapy such as proton or carbon ion therapy. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IWM, regulated under 21 CFR 892.5050, within the Radiology medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    IWM
    Device Class
    FDA class 2
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K872369 LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM