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

    MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235

    K Number: K101508 · Decision Aug 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    91
    Applicant Total
    13
    Review Days
    66

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    Basic Information

    Device Name
    MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
    K Number
    K101508
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ion Beam Applications S.A.
    Date Received
    June 1, 2010
    Decision Date
    August 6, 2010
    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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