BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY

    K Number: K850543 · Decision May 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    47
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY
    K Number
    K850543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Atomic Energy of Canada
    Date Received
    February 11, 1985
    Decision Date
    May 10, 1985
    Product Code
    IWB
    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
    IWB System, Radiation Therapy, Radionuclide

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