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510(k) Data Aggregation

    K Number
    K043336
    Device Name
    OPTISTRAND, MODEL 1032S
    Manufacturer
    IBT SA
    Date Cleared
    2005-01-21

    (49 days)

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

    IBT SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptiStrand<sup>103</sup> implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, breast, cervix, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiStrand<sup>103</sup> implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
    Device Description
    OptiStrand <sup>103</sup> implants are OptiSource™ seeds (#K040766) linked together with a spacer or spacers to create a multi-seed sourcetrain.
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    K Number
    K041702
    Device Name
    EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
    Manufacturer
    IBT SA
    Date Cleared
    2004-07-16

    (24 days)

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

    IBT SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sources in EZ-Pak Preloaded Needles are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as a primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, or as a boost to the primary tumor. The source in EZ-Pak Preloaded Needles are indicated for use concurrent with or at the completion of external beam radiation therapy or chemotherapy.
    Device Description
    EZ-Pak is a packaging change to InterSource 103 (#K973328), InterSource 125 (#K9984235) and InterStrand ® (#K011155). There is no change in the intended use of these cleared sources. Please see the referenced Premarket Notification documents for Statements of Intended Use.
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