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

    AOS ORION IR-192 SOURCE CABLE

    K Number: K102811 · Decision Jun 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    148
    Applicant Total
    7
    Review Days
    247

    Basic Information

    Device Name
    AOS ORION IR-192 SOURCE CABLE
    K Number
    K102811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ALPHA-OMEGA SERVICES, INC.
    Date Received
    September 28, 2010
    Decision Date
    June 2, 2011
    Product Code
    KXK
    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
    KXK Source, Brachytherapy, Radionuclide

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