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

    10 CURIE IRDIUM 192, CSN00100-192

    K Number: K991571 · Decision Feb 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    9
    Review Days
    293

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    Basic Information

    Device Name
    10 CURIE IRDIUM 192, CSN00100-192
    K Number
    K991571
    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
    May 5, 1999
    Decision Date
    February 22, 2000
    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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    K062824 AOS UNIVERSAL CONECTING GUIDE TUBE
    K062823 AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES
    K062826 AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
    K062825 AOS MARKER SEEDS
    K964910 AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS