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

    ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY

    K Number: K033339 · Decision Dec 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    69
    Applicant Total
    170
    Review Days
    74

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    Basic Information

    Device Name
    ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
    K Number
    K033339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Varian Medical Systems, Inc.
    Date Received
    October 17, 2003
    Decision Date
    December 30, 2003
    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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