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510(k) Data Aggregation

    K Number
    K070659
    Device Name
    BIOLUCENT APPLICATOR KIT
    Manufacturer
    BIOLUCENT, INC.
    Date Cleared
    2007-04-04

    (26 days)

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

    BIOLUCENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
    Device Description
    The BioLucent Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The BioLucent Applicator is provided sterile and is a single use device.
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    K Number
    K062830
    Device Name
    BIOLUCENT APPLICATOR KIT
    Manufacturer
    BIOLUCENT, INC.
    Date Cleared
    2006-10-20

    (30 days)

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

    BIOLUCENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioLucent Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
    Device Description
    Not Found
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    K Number
    K062141
    Device Name
    MAMMOPAD RADIOLUCENT CUSHION
    Manufacturer
    BIOLUCENT, INC.
    Date Cleared
    2006-09-13

    (48 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLUCENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology.
    Device Description
    MammoPad is a radiolucent foam cushion used during radiologic visualization of the breast. MammoPad is non-sterile and is a single use device.
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    K Number
    K061241
    Device Name
    BIOLUCENT APPLICATOR, MODEL RTA-XX
    Manufacturer
    BIOLUCENT, INC.
    Date Cleared
    2006-07-28

    (86 days)

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

    BIOLUCENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
    Device Description
    The BioLucent Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The BioLucent Applicator is provided sterile and is a single use device.
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    K Number
    K053595
    Device Name
    CURAY CUSTOM SEED ARRAY
    Manufacturer
    BIOLUCENT, INC.
    Date Cleared
    2006-02-28

    (67 days)

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

    BIOLUCENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used concurrent with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.
    Device Description
    The CuRay Custom Seed Array is an integral assembly containing radionuclide source seeds, spacers, and markers which are custom loaded according to a prescribed treatment plan. The CuRay Custom Seed Array is provided sterile and is a single use device.
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    K Number
    K003795
    Device Name
    BIOLUCENT MAMMOGRAPHY CUSHION
    Manufacturer
    BIOLUCENT, INC.
    Date Cleared
    2001-02-14

    (68 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLUCENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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