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

    I-125 SEEDS, CODE: 6711

    K Number: K914281 · Decision Nov 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    9
    Review Days
    59

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    Basic Information

    Device Name
    I-125 SEEDS, CODE: 6711
    K Number
    K914281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medi-Physics Inc. Dba Nycomed Amersham Imaging
    Date Received
    September 24, 1991
    Decision Date
    November 22, 1991
    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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    Other Clearances by Medi-Physics Inc. Dba Nycomed Amersham Imaging

    K Number Device Name
    K010821 ECHOSEED/IODINE-125 SEEDS, MODEL 6733
    K940632 I-125 RAPID STRAND
    K921961 SDMO APPLICATOR CODE: ASN.8236
    K915156 I-125 SEEDS CODE: 6702
    K914268 I-125 SEEDS IN CARRIER, CODE: 6720
    K811677 KRYPTON CART
    K811688 TUNGSTEN SYRINGE SHIELD
    K811118 KRYPTON MASKS & TUBING