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

    IMAGYN 125 I SEED, MODEL IS 125

    K Number: K982421 · Decision Jul 31, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    18

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    IMAGYN 125 I SEED, MODEL IS 125
    K Number
    K982421
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Isotopes, Inc.
    Date Received
    July 13, 1998
    Decision Date
    July 31, 1998
    Product Code
    IWG
    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
    IWG Seed, Isotope, Gold, Titanium, Platinum

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IWG), ordered by most recent decision date.

    BRACHYTHERAPY SOURCE DEVICE, MODEL 9011

    FDA 510(k)
    FDA Class 2 ·Radiology

    GOLD SEADS

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by International Isotopes, Inc.

    K Number Device Name
    K992963 I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401