Search Results
Found 4 results
510(k) Data Aggregation
K Number
K994018Device Name
PHARMASEED, MODEL BT-125-3
Manufacturer
Date Cleared
2000-07-17
(234 days)
Product Code
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
SYNCOR PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of Syncor Pharmaceuticals' BT-125-3 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 turnors or in residual turnors following completion of a course of external radiation therapy.
Total activity of BT-125-3 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-125-3 Brachytherapy Seeds
Ask a Question
Ask a specific question about this device
K Number
K994016Device Name
PHARMASEED, MODEL BT-103-3
Manufacturer
Date Cleared
2000-07-14
(231 days)
Product Code
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
SYNCOR PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of Syncor Pharmaceuticals' BT-103-3 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.
Device Description
PharmaSeed BT-103-3 Brachytherapy Seeds
Ask a Question
Ask a specific question about this device
K Number
K992007Device Name
PHARMASEED, MODEL BT-103-1
Manufacturer
Date Cleared
2000-01-14
(213 days)
Product Code
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
SYNCOR PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of Syncor Pharmaceuticals' BT-103-1 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-103-1 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
Not Found
Ask a Question
Ask a specific question about this device
K Number
K992008Device Name
PHARMASEED, MODEL BT-125-1
Manufacturer
Date Cleared
1999-12-23
(191 days)
Product Code
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
SYNCOR PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of Syncor Pharmaceuticals' BT-125-1 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1