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510(k) Data Aggregation
K Number
K161396Device Name
SPEC Model M23
Manufacturer
Source Production and Equipment Co.,Inc.
Date Cleared
2016-08-17
(90 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. (SPEC) Model M23 Source Assembly, with individual activity up to 27 Ci, is indicated for temporary interstitial, 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.
Device Description
SPEC Model M23 is a singly-encapsulated 168 ftterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive 160Ytterbium Oxide pellets. The pellets are sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
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K Number
K161395Device Name
SPEC Model M13
Manufacturer
Source Production and Equipment Co.,Inc.
Date Cleared
2016-07-06
(48 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 M13 192Iridium Brachytherapy Source, with individual activity up to 12 Ci, is indicated for temporary interstital, intraluminal, intraoperative or surface application to treat selected localized turnors. 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.
Device Description
Source Production & Equipment Co., Inc. Model M13 192 ridium Brachytherapy Source is a sinqly-encapsulated 1921ridium 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.
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K Number
K150895Device Name
SPEC Model M16
Manufacturer
Source Production and Equipment Co.,Inc.
Date Cleared
2015-06-19
(78 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. (SPEC) Model M16 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Best Medical High Dose Rate Remote Afterloader. The Model M16 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.
Device Description
SPEC Model M16 is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a solid radioactive 192Iridium pellet. The pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
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