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510(k) Data Aggregation
K Number
K993701Device Name
PHARMASEED, MODEL BT-125-2
Manufacturer
SYNCOR INTERNATIONAL, INC.
Date Cleared
2000-06-09
(220 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
SYNCOR INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of Syncor Pharmaceuticals' BT-125-2 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor.
These seeds are indicated for permanent interstitial treatment of tumors which are localized and unresectable, and which have a slow growth rate and low to moderate radiosensitivity. Superficial, intrathoracic, and intraabdominal tumors, such as those in the head, neck, lungs, pancreas and prostate are commonly treated in this manner. The seeds may also be implanted in recurrent tumors or in residual tumors following completion of a course of external radiation therapy.
Total activity of BT-125-2 seeds required for treatment is dependent upon the tumor volume and the radiation history of the site. To calculate the total activity needed, determine the placement of the sources in the tissue, and evaluate the dose distribution achieved, established practice should be followed.
Device Description
PharmaSeed Model BT-125-2
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K Number
K993700Device Name
PHARMASEED, MODEL BT-103-2
Manufacturer
SYNCOR INTERNATIONAL, INC.
Date Cleared
2000-06-02
(213 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
SYNCOR INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of Syncor Pharmaceuticals' BT-103-2 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor.
These seeds are indicated for permanent interstitial treatment of tumors which are localized and unresectable, and which have a slow growth rate and low to moderate radiosensitivity. Superficial, intrathoracic, and intraabdominal tumors, such as those in the head, neck, lungs, pancreas and prostate are commonly treated in this manner. The seeds may also be implanted in recurrent tumors or in residual tumors following completion of a course of external radiation therapy.
Total activity of BT-103-2 seeds required for treatment is dependent upon the tumor volume and the radiation history of the site. To calculate the total activity needed, determine the placement of the sources in the tissue, and evaluate the dose distribution achieved, established practice should be followed.
Device Description
PharmaSeed BT-103-2 Brachytherapy Seeds
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