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510(k) Data Aggregation
K Number
K162573Device Name
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
Manufacturer
SOURCE PRODUCTION AND EQUIPMENT CO., INC.
Date Cleared
2016-11-04
(50 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
SOURCE PRODUCTION AND EQUIPMENT CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source, with individual activity up to 12 Ci, is indicated for temporary interstital, intraluminal, intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy.
The source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Elekta/Nucletron V2/V3 Afterloaders.
The intended use of the Source Production & Equipment Co., Inc. Model M14 194ridium Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.
Device Description
Source Production & Equipment Co., Inc. Model M14 194ridium Brachytherapy Source is a singly-encapsulated 192 ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1921ridium pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
The source consists of a solid 192Iridium pellet (0.6 mm dia x 3.5 mm long) singly encapsulated in stainless steel (0.9 mm dia x 4.8 mm long) and welded to a 7x7 stranded stainless steel cable (0.9 mm dia x 2022 mm long).
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