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510(k) Data Aggregation

    K Number
    K223465
    Device Name
    RadianceTx Radionuclide Brachytherapy Source
    Manufacturer
    Radiance Therapeutics Inc.
    Date Cleared
    2023-01-11

    (55 days)

    Product Code
    KXK
    Regulation Number
    892.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RadianceTx Radionuclide Brachytherapy Source (RTx-RBS) is indicated for episcleral brachytherapy of umors and benign growths. The RTx-RBS is intended for use within a compatible manual brachytherapy applicator system.
    Device Description
    Not Found
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    K Number
    K221539
    Device Name
    GammaTile
    Manufacturer
    GT Medical Technologies
    Date Cleared
    2022-11-09

    (166 days)

    Product Code
    KXK
    Regulation Number
    892.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GammaTile is indicated as a treatment for patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms.
    Device Description
    GammaTile is a device intended for the treatment of intracranial neoplasms which uses cesium-131 radioactive sources embedded in a collagen matrix. GammaTile is designed to provide “adjuvant” radiation therapy – therapy to eliminate any remaining neoplastic cells – to patients who require surgical resection of brain neoplasms. GammaTile is positioned within the resection cavity immediately after surgical excision of the brain neoplasm to deliver radiation therapy to any neoplastic cells that remain in proximity of the resection cavity.
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    K Number
    K202267
    Device Name
    Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
    Manufacturer
    Isoray Medical, Inc.
    Date Cleared
    2020-12-31

    (142 days)

    Product Code
    KXK
    Regulation Number
    892.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Isoray Medical, Inc. Cs-131 Implant Devices with SiriusTM MRI Markers are indicated for the treatment of malignant prostatic disease. These devices may be used as a primary treatment or in conjunction with other modalities. The MRI Markers are used to facilitate the anatomical localization of seeds after they have been implanted.
    Device Description
    The Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ Markers are a combination of two commercially available devices: The Isoray Medical Cs-131 Implant Devices, and the Sirius™ MRI Markers. They come in two configurations and listed below: - Isoray Medical, Inc. Cs-131 PL-7 Preloaded Strands with Sirius™ Markers - Isoray Medical, Inc. Cs-131 PL-8 Preloaded Strands with Sirius™ Markers in 18G Needles ● The Sirius™ MRI Markers combined with the Isoray Cesium-131 Implant Devices will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The Cs-131 Implant Devices are a small, cylindrical, sealed source that consists of a welded pure titanium capsule containing the low energy gamma (x-ray) emitting isotope, Cesium-131 (Cs-131), adsorbed onto an internal inorganic substrate. The external seed dimensions are 4.5 mm length and 0.8 mm diameter and the only patient-contacting material is commercially pure titanium. The Sirius™ MRI markers consist of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride: N-Acetylcysteine solution. The Sirius™ MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy seeds containing one of the following isotopes: lodine-125, Palladium-103 or Cesium-131. The Sirius™ MRI Markers combined with the Isoray Cesium-131 Brachytherapy Seeds will be used to facilitate the anatomical location of seeds after they have been implanted. The spacers are used to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physicist. They are made of PLA/PGA copolymer and are absorbable. The spacer length is variable since it is a function of how many seeds are required by the patient treatment plan. The spacers are 0.8mm in diameter. The Cs-131 Implant Devices with MRI Markers comes in two (2) configurations as listed in the table below. The seeds, spacers, and Sirius™ MRI markers are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physician or medical physicist. There are no product specific guidance documents or product specific standards for brachytherapy seeds. The subject devices are EtO sterilized and are a single-use device.
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    K Number
    K193602
    Device Name
    LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
    Manufacturer
    LV Liberty Vision Corporation
    Date Cleared
    2020-05-29

    (158 days)

    Product Code
    KXK
    Regulation Number
    892.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system.
    Device Description
    LV Liberty Vision Model 1 90Yttrium Brachytherapy Source is a singly-encapsulated 99Yttrium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive 99Yttrium element. The radioactive element is hermetically sealed in the titanium capsule and, in use, will be attached to a manual radionuclide applicator system (21 CFR 892.5650).
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    K Number
    K190839
    Device Name
    GammaTile
    Manufacturer
    GT Medical Technologies
    Date Cleared
    2020-01-23

    (297 days)

    Product Code
    KXK
    Regulation Number
    892.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GammaTile is indicated as a treatments with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms
    Device Description
    GammaTile is a device intended for the treatment of intracranial neoplasms which uses cesium-131 radioactive sources embedded in a collagen matrix. GammaTile™ is designed to provide "adjuvant" radiation therapy - therapy to eliminate any remaining neoplastic cells - to patients who require surgical resection of brain neoplasms. GammaTile is positioned within the resection cavity immediately after surgical excision of the brain neoplasm to deliver radiation therapy to any neoplastic cells that remain in proximity of the resection cavity.
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    K Number
    K191324
    Device Name
    CivaDerm
    Manufacturer
    CivaTech Oncology Inc.
    Date Cleared
    2019-09-20

    (127 days)

    Product Code
    KXK, ONL
    Regulation Number
    892.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CivaDerm™ Pd103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can be used either as primary treatment for residual disease after excision of primary or recurrent tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.
    Device Description
    The CivaDerm utilizes biocompatible materials and bioabsorbable polymers to encapsulate Pd-103, a radionuclide with a long history in radiotherapy. CivaDerm is a planar unidirectional source intended to deliver x-ray radiation for surface brachytherapy procedures. By utilizing gold backing with the radionuclide. CivaDerm provides radiation in one direction. This allows it to target radiation dose to a contoured exterior surface without irradiating surrounding healthy tissue.
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    K Number
    K190296
    Device Name
    GammaTile
    Manufacturer
    GT Medical Technologies
    Date Cleared
    2019-03-13

    (30 days)

    Product Code
    KXK
    Regulation Number
    892.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GammaTile is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms
    Device Description
    GammaTile is a device intended for the treatment of recurrent intracranial neoplasms which uses cesium-131 radioactive sources embedded in a collagen matrix. GammaTile™ is designed to provide “adjuvant" radiation therapy – therapy to eliminate any remaining neoplastic cells – to patients who require surgical resection of recurrent brain neoplasms. GammaTile is positioned within the resection cavity immediately after surgical excision of the brain neoplasm to deliver radiation therapy to any neoplastic cells that remain in proximity of the resection cavity.
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    K Number
    K180515
    Device Name
    GammaTile
    Manufacturer
    Isoray Medical Inc.
    Date Cleared
    2018-07-06

    (129 days)

    Product Code
    KXK
    Regulation Number
    892.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GammaTileTM is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms.
    Device Description
    The GammaTile™ is a device, intended for the treatment of recurrent intracranial neoplasms that uses cesium-131 radioactive sources embedded in a collagen matrix. The GammaTile™ is designed to provide "adjuvant" radiation therapy therapy to eliminate any remaining neoplastic cells - to patients who require surgical resection of recurrent brain neoplasms. GammaTile™ is positioned within the resection cavity immediately after surgical excision of the brain neoplasm to deliver radiation therapy to any neoplastic cells that remain in proximity of the resection cavity.
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    K Number
    K171487
    Device Name
    Sirius MRI Marker NS
    Manufacturer
    C4 Imaging, LLC
    Date Cleared
    2017-08-25

    (95 days)

    Product Code
    KXK
    Regulation Number
    892.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sirius MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy seeds containing one of the following isotopes: Iodine 125 (1251), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy. The Sirius MRI Marker NS is intended to facilitate the anatomical localization of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. It is intended to be imaged under MRI within sixty (60) days of implantation. The Sirius MRI Marker NS is supplied non-sterile and will need to be sterilized by the end-user using either gamma radiation or ethylene oxide.
    Device Description
    C4 Imaging's Sirius MRI Marker NS consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride:N-Acetylcysteine solution. It is used as an accessory to radionuclide sources (seeds) during prostate brachytherapy procedures. The length of the capsule is 5.5 mm and the diameter is 0.8 mm. The Sirius MRI Marker NS will be supplied non-sterile and will be sterilized by the end-user using ethylene oxide or gamma radiation.
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    K Number
    K163572
    Device Name
    LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
    Manufacturer
    LV Liberty Vision Corp.
    Date Cleared
    2017-03-15

    (86 days)

    Product Code
    KXK
    Regulation Number
    892.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system.
    Device Description
    LV Liberty Vision Model 1 ®Yttrium Brachytherapy Source is a singly-encapsulated ®º (ttrium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive ®Yttrium element. The radioactive element is hermetically sealed in the titanium capsule and, in use, will be attached to a manual radionuclide applicator system (21 CFR 892.5650).
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