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

    THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL

    K Number: K895442 · Decision Dec 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    69
    Applicant Total
    1
    Review Days
    97

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    Basic Information

    Device Name
    THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL
    K Number
    K895442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Altek Corp.
    Date Received
    September 8, 1989
    Decision Date
    December 14, 1989
    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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