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

    RADIOACTIVE IODINE-125 SOURCES

    K Number: K912170 · Decision Aug 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    9
    Review Days
    85

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    Basic Information

    Device Name
    RADIOACTIVE IODINE-125 SOURCES
    K Number
    K912170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Best Industries
    Date Received
    May 16, 1991
    Decision Date
    August 9, 1991
    Product Code
    IWI
    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
    IWI Source, Isotope, Sealed, Gold, Titanium, Platinum

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    Other Clearances by Best Industries

    K Number Device Name
    K940121 IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS
    K940119 ROYAL MARSDEN GOLD GRAIN GUN
    K933410 IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES
    K932242 RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345
    K930570 RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES
    K924290 BEST INDUSTRIES CARTRIDGE & GUN
    K924261 RADIOACTIVE CESIUM-131 SEEDS/SOURCES
    K910862 VARIOUS TEMPLATE APPLICATORS