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510(k) Data Aggregation

    K Number
    K103319
    Device Name
    I-SEED
    Manufacturer
    THERAGENICS CORP.
    Date Cleared
    2011-01-03

    (52 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERAGENICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors may be recurrent or residual, following external beam or excision of primary tumor.
    Device Description
    The I-Seed Model AgX100 is an Iodine 125 brachytherapy source. A silver rod serves as the substrate for the I-125 and as a radiopaque marker and is contained within a titanium tube sealed at both ends with a laser welded dome. The seed is 4.5 mm long and 0.8 mm in diameter.
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    K Number
    K072296
    Device Name
    POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
    Manufacturer
    THERAGENICS CORP.
    Date Cleared
    2007-09-26

    (40 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERAGENICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Point of Care Stranding System provides a method for the physician to custom configure and assemble sterile TheraSeed® strands in the operating room at the time of the implant procedure. The Point of Care System may also be used to custom load sterile I-Seed in non-stranded configurations.
    Device Description
    The Point of Care Stranding System is designed to facilitate intra-operative treatment planning by providing a means of joining sterile TheraSeed® sources with sterile spacers of varying lengths to form the desired strand configuration. The device also facilitates transfer of the sterile strand either directly into a CP Medical brachytherapy needle, or via a transfer tube into a MICK style applicator needle. The device system consists of the following components: Assembly Device, Seed Magazine, Spacer Cartridges, Stylet, and Transfer Tube (optional).
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    K Number
    K043596
    Device Name
    THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
    Manufacturer
    THERAGENICS CORP.
    Date Cleared
    2005-01-26

    (28 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERAGENICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and spacers custom loaded according to the treatment plan. The brachytherapy source is intended to treat localized, unresectable turnors with low to moderate radiosensitivity. Tumors may be recurrent or residual following external beam or excision of primary tumor and may be superficial, intrathoracic (head, neck, lung), or intra-abdominal (pancreas, prostate).
    Device Description
    TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and bioabsorbable spacers custom loaded according to the treatment plan. The variable seed spacing available with TheraLoad™ allows the treating medical physicist to specify individual patient prescriptions. The customized order can contain a variable number of seeds and/or spacers (1-12 total components). The treating medical physicist determines the total number of active seeds required for each order. The spacer material is biocompatible and commonly used in implantable medical devices.
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    K Number
    K010283
    Device Name
    THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200
    Manufacturer
    THERAGENICS CORP.
    Date Cleared
    2001-04-26

    (86 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERAGENICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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