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

    MODEL 555 010 XY CONVERSION(55010)

    K Number: K960737 · Decision May 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    69
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    MODEL 555 010 XY CONVERSION(55010)
    K Number
    K960737
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Systems Supply Services, Inc.
    Date Received
    February 23, 1996
    Decision Date
    May 22, 1996
    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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