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510(k) Data Aggregation

    K Number
    K162573
    Device 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
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SOURCE PRODUCTION **AND EQUIPMENT CO

    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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    K Number
    K161396
    Device Name
    SPEC Model M23
    Manufacturer
    Source Production and Equipment Co.,Inc.
    Date Cleared
    2016-08-17

    (90 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Source Production **and Equipment Co

    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
    K161395
    Device Name
    SPEC Model M13
    Manufacturer
    Source Production and Equipment Co.,Inc.
    Date Cleared
    2016-07-06

    (48 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Source Production **and Equipment Co

    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
    K150895
    Device Name
    SPEC Model M16
    Manufacturer
    Source Production and Equipment Co.,Inc.
    Date Cleared
    2015-06-19

    (78 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Source Production **and Equipment Co

    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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    K Number
    K132969
    Device Name
    SPEC MODEL M15
    Manufacturer
    SOURCE PRODUCTION & EQUIPMENT CO., INC.
    Date Cleared
    2014-01-02

    (101 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SOURCE PRODUCTION **& EQUIPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Source Production & Equipment Co., Inc. (SPEC) Model M15 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal, intraoperative or surface application to treat selected tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Nucletron microSelectron Classic High Dose Rate Remote Afterloader. The Model M15 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 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 M15 is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a stainless steel capsule containing 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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    K Number
    K090366
    Device Name
    SPEC MODEL M-31
    Manufacturer
    SOURCE PRODUCTION & EQUIPMENT CO., INC.
    Date Cleared
    2009-04-22

    (68 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SOURCE PRODUCTION **& EQUIPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Source Production & Equipment Cc., Inc. (SPEC) Model M-31 198 Ytterbium Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial. intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. Model M-31 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.
    Device Description
    SPEC Model M-31 is a singly-encapsulated 18° vtterbium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive 19° tterbium pellet. The capsu the pellet consists of a titanium tube which is closed on each end with titanium wires which are laser-welded to the tubing.
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    K Number
    K052947
    Device Name
    SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE
    Manufacturer
    SOURCE PRODUCTION & EQUIPMENT CO., INC.
    Date Cleared
    2006-04-19

    (181 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SOURCE PRODUCTION **& EQUIPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Source Production & Equipment Co., Inc. (SPEC) Model M-19 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal or 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
    SPEC Model M-19 is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 199 ridium 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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