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

    GENESYS AND THE ROI

    K Number: K910002 · Decision Jul 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    201

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    Basic Information

    Device Name
    GENESYS AND THE ROI
    K Number
    K910002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    The Complete Systems Corp. Genesys
    Date Received
    January 2, 1991
    Decision Date
    July 22, 1991
    Product Code
    JAI
    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
    JAI Couch, Radiation Therapy, Powered

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