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Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography). Mobius3D is not a treatment planning system. It is to be used only by trained radiation oncology personnel as a quality assurance tool.

Mobius3D is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a Treatment Planning System (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software only QA tool, Mobius3D never comes into contact with patients.

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The Intracavitary/Interstitial System is intended for cancer treatment of the uterus, cervix, and vagina using HDR or PDR brachytherapy.

The Intracavitary/Interstitial System is a device with two (2), hollow, open-ended catheters which connect to applicator sets with ovoids, ring caps or templates on the distal end. The guide tubes extend outside of the patient. An interstitial needle is guided through the guide tube from outside the patient to an interstitial hole in the applicator. The proximal end of the guide tube contains a fixation mechanism for fixing the needle insertion depth between needle insertion and removal of the implant. The Intracavitary/Interstitial System is intended to be used with the following required accessories: Plastic Needles (K120341) and Leak Stop Channel Markers (K152018).

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vaqina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy. The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. The intended patient population includes adult female patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The subject device is intended to be used in a healthcare or treatment facility by trained and qualified personnel. The key performance characteristics of this applicator set are as follows: - . The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop. - 3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort. - The tandems and the pivot assembly are made from strong, lightweight titanium. - Four different ovoid sizes to allow for varying anatomy. - . Channel marking on the intrauterine tandems and colpostat tandems for easy identification. - . Ability to image the patient using CT imaging. - Ability to image the patient using MR imaging. - Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place. - . Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation. - Can be manually or machine cleaned, disinfected and steam sterilizable. - Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader. - Suitable for patient contact for a period of less than 30 days

IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for monitoring patient motion including respiratory patterns. It allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.

IDENTIFY is a system for motion monitoring during radiotherapy treatment simulation and delivery. It incorporates patient safety, quality, and workflow efficiency. Its high precision SGRT cameras support proper patient positioning and enable to monitor the patient's respiratory motion and to detect intra-fraction patient position changes during the treatment.

Embozene Color-Advanced Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). The device is not intended for neurovascular use.

Embozene Color-Advanced Microspheres (hereafter may be referenced as Embozene Microspheres or Embozene) are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer shell (Polyzene-F). The microspheres are suspended in liquid and then injected into the bloodstream to permanently occlude blood vessels. They are used to stop bleeding when the underlying lesion is not likely to heal or block arteries supplying a tumor to cause tumor necrosis and/or shrinkage. Embozene Color-Advanced Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml of microspheres in approximately 7 ml of transport solution. The Embozene Microspheres are available in 40-1300 µm sizes.

The Mould Probe MR Safe is intended for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy. IORT = Intraoperative Radiation Therapy.

The Mould Probe MR Safe is a Brachytherapy applicator. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment. The Mould Probe MR Safe is intended for HDR or PDR brachytherapy and the key performance characteristics are as follows: - Suitable for intraoperative, intraluminal, and interstitial brachytherapy. - Can be used for surface treatments in combination with the suitable Varian flap. - Equipped with stabilizing mandrins for easy insertion. - MR Safe, if used without mandrins. - CT compatible, if used without mandrins. - Elastomer material construction provides increased flexibility for easy placement as well as luminal rigidity, which prevents kinks. - Steam sterilizable. - Suitable for patient contact for up to 24 hours. The stainless steel mandrins are not intended to have patient contact.

The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

ARIA Radiation Therapy Management (ARIA RTM) manages several treatment information such as images and treatment data to prepare plans created for treatment and review post-treatment images and records. It also provides quality assurance options. ARIA RTM does not directly act on the patient. ARIA RTM is applied by trained medical professionals in the process of preparation and management of radiotherapy treatments for patients.

The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal radiation (brachytherapy) treatments.

Eclipse provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. It is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments. Eclipse is used for planning external beam radiation therapy treatments employing photon energies between 1 and 50 MV, electron energies between 1 and 50 MeV, for proton energies between 50 and 300 MeV, and for planning internal radiation (brachytherapy) treatments with any clinically approved radioisotope. The treatment planning system utilizes a patient model or virtual patient derive from medical imaging techniques to simulate, calculate and optimize the radiation dose distribution inside the body during a treatment procedure in order to ensure effective treatment of the tumor but to minimize damage to surrounding tissue.

The Intraluminal Applicator Set is intended for intraluminal brachytherapy treatments including endobronchial treatments and treatments on body sites such as the bile duct using HDR brachytherapy.

The Intraluminal Applicator Set is intended for intrapy treatments including endobronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy. The Intraluminal Applicator Set acts to guide the radioactive source to the correct location for treatment. Key performance characteristics are as follows: - . Suitable for treating body sites allowing insertion of a catheter. - CT compatible. ● - MR Compatibility: Safe. ● - Fits a 2 mm diameter bronchoscope biopsy channel allowing for easy insertion. - Elastomer construction provides increased flexibility for easy placement and luminal rigidity to avoid kinks. ● - Nylon monofil adds luminal stability during catheter insertion and manipulation. ● - Comes with 2.8 mm spacing tubes, which minimize surface dose. . - . Spacing tubes enable secure placement during treatment. - The bronchial catheter and monofil are supplied sterile, and for single use. - . The guide tubes, the bronchial catheter, the bite catheters are intended for continuous use for less than 24 hours of contact with patients.