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

    CTM (CLINAC TREATMENT MONITOR)

    K Number: K770202 · Decision Feb 7, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    69
    Applicant Total
    86
    Review Days
    7

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    Basic Information

    Device Name
    CTM (CLINAC TREATMENT MONITOR)
    K Number
    K770202
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Varian Assoc., Inc.
    Date Received
    January 31, 1977
    Decision Date
    February 7, 1977
    Product Code
    KPQ
    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
    KPQ System, Simulation, Radiation Therapy

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