BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Sumitomo Proton Therapy System

    K Number: K160612 · Decision Aug 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    91
    Applicant Total
    2
    Review Days
    167

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    Basic Information

    Device Name
    Sumitomo Proton Therapy System
    K Number
    K160612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sumitomo Heavy Industries, Ltd.
    Date Received
    March 3, 2016
    Decision Date
    August 17, 2016
    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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    Other Clearances by Sumitomo Heavy Industries, Ltd.

    K Number Device Name
    K130426 SUMITOMO PROTON THERAPY SYSTEM