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Found 4 results
510(k) Data Aggregation
K Number
K103319Device Name
I-SEED
Manufacturer
THERAGENICS CORP.
Date Cleared
2011-01-03
(52 days)
Product Code
KXK
Regulation Number
892.5730Why 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
K072296Device Name
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
Manufacturer
THERAGENICS CORP.
Date Cleared
2007-09-26
(40 days)
Product Code
KXK
Regulation Number
892.5730Why 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
K043596Device 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
892.5730Why 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
K010283Device Name
THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200
Manufacturer
THERAGENICS CORP.
Date Cleared
2001-04-26
(86 days)
Product Code
KXK
Regulation Number
892.5730Why 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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