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

    PINNACLE3 SMARTARC

    K Number: K090808 · Decision Apr 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    51
    Same Product Code
    243
    Applicant Total
    111
    Review Days
    9

    Basic Information

    Device Name
    PINNACLE3 SMARTARC
    K Number
    K090808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PHILIPS MEDICAL SYSTEMS, INC.
    Date Received
    March 25, 2009
    Decision Date
    April 3, 2009
    Product Code
    MUJ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUJ System, Planning, Radiation Therapy Treatment

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