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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 Gating Reflector Block is an accessory medical device indicated for adult and pediatric patients undergoing radiotherapy treatment simulation and/or delivery. GRB is a reusable device indicated for monitoring patient motion including respiratory patterns.

The Gating Reflector Block is a passive hardware device used for tracking the respiratory motion of the patient. It is intended to be used as an accessory to with Respiratory Gating System Scanners (K213927); TrueBeam STx™, Edge™, VitalBeam (K213977); and RPM Respiratory Gating System 1.7MR2 (K102024) to support motion management during imaging acquisition or radiation therapy treatment. The Gating Reflector Block (Figure 01) has the following major components: 1. Body 2. Reflective Markers The device has 4 mounted optical markers such that the reflected light can be processed by a camera to quantify the displacement of the markers, thus obtaining the patient's breathing curve. The device consists of a plastic block and back plate and the optical markers. The optical lenses reflect the IR light wavelengths used by parent devices. Their arrangement ensures that the spatial displacement and the rotation of the block is detectable by optical monitoring systems. The alignment to the treatment room lasers is ensured by the printed alignment marks on the top and the sides of the block. The major function of the device is to act as a surrogate device for tracking patient motion. Current parent devices track respiratory motion after placing the gating block on the chest of the patient. The IR reflectors are used by the parent devices to calculate the position and rotation of the block.

The Titanium Fletcher-style Applicator Set - Defined Geometry is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina using HDR or PDR brachytherapy. The Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for HDR or PDR brachytherapy.

The Titanium Fletcher-style Applicator Set – Defined Geometry is intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina when performing HDR or PDR 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 Titanium Fletcher-Style Applicator Set Defined Geometry includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Titanium Fletcher-Style Applicator Set Defined Geometry is intended to be used in a healthcare or treatment facility by trained and qualified personnel. This 510(k) submission is also inclusive of the Smit Cervical Sleeve which is an optional component that may be used with the Titanium Fletcher Style Applicator Set Defined Geometry but is not required to successfully perform the intended use.

ONCOZENE Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors including hepatoma.

ONCOZENE Microspheres (hereafter may be referenced as ONCOZENE Microspheres or ONCOZENE) 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. ONCOZENE Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml or 3 ml of microspheres in approximately 7 ml of transport solution. The ONCOZENE Microspheres are available in 40, 75 and 100 um sizes.

The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.

The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is an applicator for intracavitary 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 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 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 Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.