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510(k) Data Aggregation

    K Number
    K180571
    Device Name
    GammaPod
    Manufacturer
    Xcision Medical Systems, LLC
    Date Cleared
    2018-04-04

    (30 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xcision Medical Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
    Device Description
    The GammaPod™ is a teletherapy device that uses rotating, multi-source Cobalt-60 gamma-ray emitting sources to noninvasively deliver a focal dose of radiation to a partial volume of a human breast of a patient in the prone position while sparing the surrounding normal tissues and structures. The GammaPod system contains 4 main components: i. GammaPod irradiation unit, ii. Imager loader system, iii. Breast immobilization system, and iv. Treatment planning system.
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    K Number
    K172706
    Device Name
    GammaPod - Model A
    Manufacturer
    Xcision Medical Systems, LLC
    Date Cleared
    2017-12-22

    (106 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xcision Medical Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
    Device Description
    The GammaPod™ is a teletherapy device that uses rotating, multi-source Cobalt-60 gamma-ray emitting sources to noninvasively deliver a focal dose of radiation to a partial volume of a human breast of a patient in the prone position while sparing the surrounding normal tissues and structures. The GammaPod system contains 4 main components: - GammaPod irradiation unit. - Imager loader system. - Breast immobilization system. - Treatment planning system.
    Ask a Question

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