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

    ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501

    K Number: K991526 · Decision Jun 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    7
    Review Days
    45

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    Basic Information

    Device Name
    ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
    K Number
    K991526
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagyn Medical Technologies, Inc.
    Date Received
    May 3, 1999
    Decision Date
    June 17, 1999
    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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