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510(k) Data Aggregation
K Number
K043336Device Name
OPTISTRAND, MODEL 1032S
Manufacturer
IBT SA
Date Cleared
2005-01-21
(49 days)
Product Code
KXK
Regulation Number
892.5730Why 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
K041702Device 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
892.5730Why 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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