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

    OUR ROTATING GAMMA SYSTEM

    K Number: K970647 · Decision May 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    47
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    OUR ROTATING GAMMA SYSTEM
    K Number
    K970647
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Our Scientific Intl., Inc.
    Date Received
    February 20, 1997
    Decision Date
    May 20, 1997
    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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