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510(k) Data Aggregation

    K Number
    K213942
    Device Name
    Esteya
    Manufacturer
    Nucletron B.V.
    Date Cleared
    2022-01-11

    (25 days)

    Product Code
    JAD
    Regulation Number
    892.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nucletron B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Esteya is intended to deliver X-ray radiation for superficial radiotherapy procedures and surface brachytherapy. Applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Keloids and Cutaneous Lymphomas (B and T cell).
    Device Description
    The Esteva is designed for high dose rate treatment of skin surface lesions. The Esteva utilizes a mobile treatment unit with an isotope free small 69.5 kV X-rav source that focuses the treatment dose directly to the skin lesion with the aid of a shielded surface applicator. This technique provides a uniform dose to the underlying tissue within minutes. The small X-ray source is activated by the treatment control panel that is located adjacent to the treatment area where the operator is protected from radiation exposure during the patient treatment. The dedicated computer system of Esteya provides fractionated treatment times, plan approval, patient information and treatment reports in a protected database which is administrator controlled. The quality of the X-ray source output is measured on a daily basis with a dedicated quality assurance device that Is connected directly to the treatment unit. This quality assurance check ensures consistent and accurate electronic brachytherapy & superficial radiotherapy treatment.
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    K Number
    K151272
    Device Name
    Henschke Titanium Applicator Set
    Manufacturer
    NUCLETRON B.V.
    Date Cleared
    2015-06-23

    (41 days)

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

    NUCLETRON B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Henschke Titanium Applicator Set is designed for treatment of the cervix and endometrium
    Device Description
    The Henschke Titanium Applicator Set is a modification of the Henschke Applicator Set (K953946). It is intended for intracavitary brachytherapy and is used for cancer treatment of the cervix and endometrium. The Henschke Titanium Applicator Set is a gynecological applicator for Brachytherapy procedures. The applicator uses an intrauterine tube and two colpostat tubes. A colpostat cap can be placed on each colpostat tube. The tubes guide the radioactive source of the afterloader to the location where treatment is to be applied. Transfer tubes are required to connect the applicator to the afterloader. With the adjustable cervical stopper, the intrauterine tube-length can exactly be fitted to the patient's anatomy. The intrauterine tube has adjustment centimeter-markings. The device is compatible with Nucletron afterloaders. The applicator is made of Titanium and PPSU, to minimize distortion on CT imaging. This enables conformal treatment planning with the use of CT images.
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    K Number
    K140803
    Device Name
    LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM
    Manufacturer
    NUCLETRON B.V.
    Date Cleared
    2014-06-26

    (87 days)

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

    NUCLETRON B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luneray is intended for interstitial brachytherapy of soft tissue that allows the insertion of this flexible applicator, e.g .: - Abdominal structures / organs (e.g. urinary . bladder) - Head and neck (e.g. ear, lip, nose, tongue, oral . mucosa) - Skin (e.g. keloids) . - Soft tissue sarcoma . Luneray enables minimally invasive procedures to be performed both manually and laparoscopically.
    Device Description
    Luneray is a pre-assembled, sterile needle-catheter combination for interstitial brachytherapy treatments. The needle is inserted into the tissue and pulls the catheter through the tissue. After insertion the needle is removed from the catheter by cutting it off the catheter. Radiation treatment planning can be based on X-ray and CT images. X-ray markers shall be used during the imaging procedure, to enable catheter reconstruction in the planning software. The applicator is connected to a Nucletron brachytherapy afterloader for radiation treatment.
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    K Number
    K132816
    Device Name
    ONCENTRA BRACHY
    Manufacturer
    NUCLETRON B.V.
    Date Cleared
    2014-06-13

    (277 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NUCLETRON B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
    Device Description
    Oncentra Brachy 4.4 is a radiation therapy treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. Oncentra Brachy 4.4 is a brachytherapy treatment planning only version of the Oncentra treatment planning system (Oncentra 4.2- K121448) and does not include Oncentra external beam treatment planning capabilities. Oncentra Brachy 4.4 includes all Oncentra software that is required for brachytherapy treatment planning which includes - Anatomy Module: The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROIs) related to the patient anatomy and target volumes for treatment planning. The AM allows the user to create and edit image registration between image series so that image fusion tools can be utilized. - Connectivity Module: The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra Brachy system from external sources, and data output from the system to external sources. - Brachy Planning Module: The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations. The software allows reconstruction of the implant from external images, identification of the radioactive sources, optimization methods, displayed dose distributions and output of treatment times. - Evaluator Module: The Oncentra Evaluator (EVAL) handles the necessary tools for evaluating and comparing multiple treatment plans and dose summation of two or more plans for a selected case. The EVAL is a read-only activity with the exception of the plan approval function. - Volume Rendering: The Volume Rendering (VR) module handles visualization of plans and their corresponding dose in 3D. No plan related data is modified in this module. - Collapsed Cone Algorithm (ACE): Is a model based dose calculation that has been implemented in accordance with the AAPM TG-186 recommendations for brachytherapy uniformity. This algorithm takes into account the effects of tissue heterogeneities (normal tissue, air and bone), shields and applicators within finite patient dimensions.
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    K Number
    K132889
    Device Name
    FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
    Manufacturer
    NUCLETRON B.V.
    Date Cleared
    2014-02-26

    (163 days)

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

    NUCLETRON B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
    Device Description
    The Fletcher CT/MR Shielded Applicator Set is a modification of the Fletcher Williamson Applicator Set (K983341). It is a gynecological applicator for brachytherapy procedures. The applicator uses one intrauterine tube and two ovoid tubes for treatment of the cervix and endometrium cancer. The tubes quide the radioactive source of the afterloader to the location where treatment is to be applied. Tungsten allov shielding is incorporated in the ovoid to lower the dose in organs like rectum and bladder during treatment. The shielding position in the ovoid is adjustable, enabling CT imaging with few artifacts. For MR data acquisition and X-ray it is not necessary to move the shields. The Fletcher CT/MR Shielded Applicator Set is available in two variations and is compatible with Nucletron afterloaders and accessories.
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    K Number
    K132874
    Device Name
    LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM
    Manufacturer
    NUCLETRON B.V.
    Date Cleared
    2014-02-21

    (161 days)

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

    NUCLETRON B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LumenCare Azure is intended for intraluminal brachytherapy and is used for treatment of the lung or other lumen, e.g. bronchus and bile duct. The LumenCare Azure is designed to fit in the working channel of an endoscope.
    Device Description
    The LumenCare Azure is a modification of the Lumencath Applicator Set. It is intended for intraluminal brachytherapy and is used for treatment of the lung and any lumen that allow the insertion of this flexible applicator, e.g. bronchus and bile duct. The applicator consists of a flexible thin catheter and accessories that assist during applicator placement, imaging and treatment. The catheter fits in the working channel of an endoscope. This way, the catheter can be positioned into the treatment area under direct visual control. The catheter of the LumenCare Azure can be delivered in three variants. These variants only differ in dimensions, i.e. catheter diameter (outer diameter and inner diameter) and total length of the catheter. The devices are used as accessories to Nucletron afterloaders.
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    K Number
    K132092
    Device Name
    ESTEYA
    Manufacturer
    NUCLETRON B.V.
    Date Cleared
    2013-09-26

    (83 days)

    Product Code
    JAD
    Regulation Number
    892.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    NUCLETRON B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Esteya electronic brachytherapy system is intended to deliver x-ray radiation for suface brachytherapy procedures. Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Malingna Melanoma, Keloids and Cutaneous Lymphoma (B and T cell).
    Device Description
    The Esteya Electronic Brachytherapy System is designed for High Dose Rate (HDR) brachytherapy treatment of skin surface lesions. The Esteya Electronic Brachytherapy System utilizes a mobile treatment unit with an isotope free small 69.5 kV X-ray source that focuses the treatment dose directly to the skin lesion with the aid of a shielded surface applicator. This technique provides a uniform dose to the underlying tissue within minutes. The small X-ray source is activated by the treatment control panel that is located adjacent to the treatment area where the operator is protected from radiation exposure during the patient treatment. The Esteya Electronic Brachytherapy dedicated computer system provides fractionated treatment times, plan approval, patient information and treatment reports in a protected database which is administrator controlled. The quality of the X-ray source output is measured on a daily basis with a dedicated quality assurance device that is connected directly to the treatment unit. This quality assurance check ensures consistent and accurate electronic brachytherapy treatment.
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