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

    STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE

    K Number: K827583 · Decision Sep 29, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    30

    Basic Information

    Device Name
    STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE
    K Number
    K827583
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    NUCLETRONIX, INC.
    Date Received
    August 30, 1982
    Decision Date
    September 29, 1982
    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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