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The EmpNia eMotus system is used to measure and record the patient's respiratory waveform to aid with respiratory-synchronized image acquisition or reconstruction during CT diagnostic imaging or radiation treatment planning procedures, where there is a risk of respiratory motion compromising the resulting image. The EmpNia eMotus system is used to derive and communicate a Gate signal to aid with organ position verification for radiation therapy treatment using CT or Xray imaging by monitoring the patient's respiratory waveform during the image acquisition, where there is a risk of respiratory motion compromising the resulting image. The EmpNia eMotus system is used to derive and communicate a Gate signal to aid with radiation therapy treatment, where there is a risk of respiratory motion compromising the resulting treatment accuracy.

The eMotus Respiratory Motion Management System ("eMotus system") is designed to monitor patient respiratory motion and to provide information about this respiratory motion to an external medical device system, such as a radiation therapy delivery device (TDD) or a diagnostic imaging device (DX). The main components of the eMotus system include: - Sensor pad with optical fiber sensors, - Optical fiber cables, - Optical transceiver, - Data acquisition computer with eMotus software application, - Communication modules for compatible external systems, and - Cables to allow data transmission between the components. The sensor pad is a single-use, disposable component with an adhesive backing that is placed directly on the patient's thorax or abdomen. The sensor pad is attached to optical fiber cables that connect to the optical transceiver, which collects optical signal data based on deflection of the sensors in response to respiratory motion. The transceiver digitizes the data and transmits it to the eMotus computer, which visualizes the data as a waveform that can be highlighted when the waveform amplitude reaches a user-specified threshold or the patient's respiratory cycle reaches a user-specified phase. The user can utilize the respiratory threshold and phase information to manually control an external TDD or DX system. When connected to an external TDD or DX, the eMotus system supports the following functions (as applicable given the functions of the external system): - **Threshold-gated therapy delivery:** Automatic gating (turning on / off) of the radiation treatment beam based on user-set parameters for the amplitude of the respiratory waveform. - **Phase-gated therapy delivery:** Automatic gating (turning on / off) of the radiation treatment beam based on user-set parameters for the phase of the respiratory waveform cycle. - **Retrospective four-dimensional planning scan:** Delivery of the respiratory waveform to an imaging device to synchronize the waveform data with the scan data, enabling retrospective four-dimensional reconstruction of the imaging session for use in treatment planning. - **Prospective four-dimensional planning scan:** Automatic patient's respiratory waveform are within preset limits, which is used to disable the radiation beam automatically. The eMotus device is an ancillary device and does not provide stand-alone therapy or diagnostic information.

Cranial 4Pi is intended for patient immobilization in radiotherapy and radiosurgery procedures. Cranial 4Pi is indicated for any medical condition in which the use of radiotherapy or radiosurgery may be appropriate for cranial and head & neck treatments.

Cranial 4Pi is an assembly of the following medical device/ accessory groups: - CRANIAL 4PI OVERLAYS (CRANIAL 4PI CT OVERLAY, CRANIAL 4PI TREATMENT OVERLAY) - CRANIAL 4PI HEADRESTS (CRANIAL 4PI HEADREST STANDARD, CRANIAL 4PI HEADREST LOW-NECK, CRANIAL 4PI HEADREST PLATFORM) - CRANIAL 4PI HEADREST INLAYS (CRANIAL 4PI HEADREST INLAY STANDARD, CRANIAL 4PI HEADREST INLAY OPEN FACE, CRANIAL 4PI HEADREST INLAY H&N, CRANIAL 4PI HEAD SUPPORT STANDARD, CRANIAL 4PI HEAD SUPPORT WIDE) - CRANIAL 4PI MASKS (CRANIAL 4PI BASIC MASK, CRANIAL 4PI OPEN FACE MASK, CRANIAL 4PI EXTENDED MASK, CRANIAL 4PI STEREOTACTIC MASK, CRANIAL 4PI STEREOTACTIC MASK 3.2MM) - CRANIAL 4PI WEDGES AND SPACERS (CRANIAL 4PI WEDGE 5 DEG., CRANIAL 4PI WEDGE 10 DEG., CRANIAL 4PI SPACER 20MM, CRANIAL 4PI INDEXING PLATE) The Cranial 4Pi Overlays are medical devices used for fixation of the patient in a CT- resp. linear accelerator - environment. The Cranial 4Pi Headrests and the Cranial 4Pi Headrest Inlays are accessories to the Cranial 4Pi Overlays to allow an indication specific positioning of the patient's head and neck. The Cranial 4Pi Wedges and Spacers are accessories to the Cranial 4Pi Headrest Platform to adapt the inclination of the head support to the patients necks. The Cranial 4Pi Masks are accessories to the Cranial 4Pi Overlays used for producing individual custom-made masks for patient immobilization to the Cranial 4Pi Overlay.

The device is intended for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment and indicated for cranial, head and neck and extracranial lesions.

RT Elements are computed-based software applications for radiation therapy treatment planning and dose optimization for linac-based conformal radiation treatments, i.e. stereotactic radiosurgery (SRS), fractionated stereotactic radiotherapy (SRT) or stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT) for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The device consists of the following software modules: Multiple Brain Mets SRS 4.5, Cranial SRS 4.5, Spine SRS 4.5, Cranial SRS w/ Cones 4.5, RT Contouring 4.5, RT QA 4.5, Dose Review 4.5, Brain Mets Retreatment Review 4.5, and Physics Administration 7.5.

The Visualase V2 ™ MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis, and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.

The Visualase MRI-Guided Laser Ablation System comprises hardware and software components used in combination with three MR-compatible (conditional), sterile, single-use, saline-cooled laser applicators with proprietary diffusing tips that deliver controlled energy to the tissue of interest. The system consists of: - a diode laser (energy source) - a coolant pump to circulate saline through the laser application - Visualase workstation which interfaces with MRI scanner's host computer - Visualase software which provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output; one monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections

MapRT is indicated for assisting with planning of radiation therapy by: - Assessing which combinations of gantry/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and - Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures

MapRT is used by radiotherapy professionals during the CT simulation and treatment planning stages of radiotherapy for collision avoidance and facilitating dose optimisation. MapRT uses two lateral wide-field cameras in simulation to deliver a full 3D model of patients and accessories. This model is then used to calculate a clearance map for every couch (x-axis) and gantry (y-axis) angles. Radiotherapy treatment plans can then be imported automatically to check beams, arcs, and the transition clearance.

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.

The PPTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation. When the patient is in the seated position using the chair, the System is indicated for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation in the head, neck and thorax.

The P-CURE Proton Therapy System (PPTS) is comprised of four main subsystems that function in tandem to generate the desired dose level and distribution at the target site: - Beam production system (Synchrotron based accelerator) - Injector – produces and delivers protons to the synchrotron - Synchrotron ring – accelerates the proton beam in circular orbit (within the ring) to the desired energy level - Extraction system - extracts the beam from the ring to the beam delivery subsystem - Beam delivery system for a single fixed beam treatment room. Steers and monitors the extracted proton pencil beam from the synchrotron to the desired treatment location (Nozzle). - Patient Positioning System (P-ARTIS). Mechanically orients the patient (seated or on supine); provides independent means of patient registration using CT (3D) and X-ray (2D) - CT system (P-ARTIS CT) - Robotic arm and chair/couch (6 Degree of freedom Couch) (P-ARTIS PPS) - X-ray system (P-ARTIS XR) - Positioning Software (P-ART) - Control and Safety Systems - Control Subsystem (TSM). Synchronizes the various subsystem actions and connects with hospital oncology information systems and PACS. - Safety Subsystem. Includes hardware and software means to ensure safe system operation for patient and personnel. It includes subsystem interlocks, treatment beam parameters monitoring, and others.

RayCare is an oncology information system intended to provide information which is used to take decisions for diagnosis, treatment management, treatment planning, scheduling, treatment and follow-up of radiation therapy, medical oncology and surgical oncology. For these disciplines, as applicable, RayCare enables the user to define the clinical treatment intent, prescribe treatment, specify the detailed course of treatment delivery, manage the treatment course and monitor the treatment course. In the context of radiation therapy, the RayCare image viewer can be used for viewing images, annotating images, performing and saving image registrations as well as image fusion to enable offline image review of patient positioning during treatment delivery. RayCare is not intended for use in diagnostic activities.

RayCare is an oncology information system intended to provide information which is used to take decisions for diagnosis, treatment management, treatment planning, scheduling, treatment and follow-up of radiation therapy, medical oncology and surgical oncology. For these disciplines, as applicable, RayCare enables the user to define the clinical treatment intent, prescribe treatment, specify the detailed course of treatment delivery, manage the treatment course and monitor the treatment course. In the context of radiation therapy, the RayCare image viewer can be used for viewing images, annotating images, performing and saving image registrations as well as image fusion to enable offline image review of patient positioning during treatment delivery. As an oncology information system, RayCare supports healthcare professionals in managing cancer care treatments. The system provides functionalities as described briefly in the sections below. These functionalities are not provided separately in different applications and have a joint purpose for the treatment of the patient. RayCare is a software-as a Medical Device with a client part that allows the user to interact with the system and a server part that performs the necessary processing and storage functions. Selected aspects of RayCare are configurable, such as adapting workflow templates to the specific needs of the clinic.

Oncospace is used to configure and review radiotherapy treatment plans for a patient with malignant or benign disease in the head and neck, thoracic, abdominal, and pelvic regions. It allows for set up of radiotherapy treatment protocols, association of a potential treatment plan with the protocol(s), submission of a dose prescription and achievable dosimetric goals to a treatment planning system, and review of the treatment plan. It is intended for use by qualified, trained radiation therapy professionals (such as medical physicists, oncologists, and dosimetrists). This device is for prescription use by order of a physician.

The Oncospace software supports radiation oncologists and medical dosimetrists during radiotherapy treatment planning. The software includes locked machine learning algorithms. During treatment planning, the Oncospace software works in conjunction with, and does not replace, a treatment planning system (TPS). The Oncospace software is intended to augment the treatment planning process by: - allowing the radiation oncologist to select and customize a treatment planning protocol that includes dose prescription (number of fractions, dose per fraction, dose normalization), a delivery method (beam type and geometry), and protocol-based dosimetric goals/objectives for treatment targets, and organs at risk (OAR); - predicting dosimetric goals/objectives for OARs based on patient-specific anatomical geometry; - automating the initiation of plan optimization on a TPS by supplying the dose prescription, delivery method, protocol-based target objectives, and predicted OAR objectives; - providing a user interface for plan evaluation against protocol-based and predicted goals. Diagnosis and treatment decisions occur prior to treatment planning and do not involve Oncospace. Decisions involving Oncospace are restricted to setting of dosimetric goals for use during plan optimization and plan evaluation. Human judgement continues to be applied in accepting these goals and updating them as necessary during the iterative beam optimization process. Human judgement is also still applied as in standard practice during plan quality assessment; the protocol-based OAR goals are used as the primary means of plan assessment, with the role of the predicted goals being to provide additional information as to whether dose to an OAR may be able to be further lowered. When Oncospace is used in conjunction with a TPS, the user retains full control of the TPS, including finalization of the treatment plan created for the patient. Oncospace also does not interface with the treatment machines. The risk to patient safety is lower than a TPS since it only informs the treatment plan, does not allow region of interest editing, does not make treatment decisions, and does not interface directly with the treatment machine or any record and verify system. Oncospace's OAR dose prediction approach, and the use of predictions in end-to-end treatment planning workflow, has been tested for use with a variety of cancer treatment plans. These included a wide range of target and OAR geometries, prescriptions and boost strategies (sequential and simultaneous delivery). Validity has thus been demonstrated for the range of prediction model input features encountered in the test cases. This range is representative of the diversity of the same feature types (describing target-OAR proximity, target and OAR shapes, sizes, etc.) encountered across all cancer sites. Given that the same feature types will be used in OAR dose prediction models trained for all sites, the modeling approach validated here is not cancer site specific, but rather is designed to predict OAR DVHs based on impactful features common to all sites. The software is designed to be used in the context of all forms of intensity-modulated photon beam radiotherapy. The planning objectives themselves are intended to be TPS-independent: these are instead dependent on the degree of organ sparing possible given the beam modality and range of delivery techniques for plans in the database. To facilitate streamlined transmission of DICOM files and plan parameters Oncospace includes scripts using the treatment planning system's scripting language (for example, Pinnacle). The Oncospace software includes an algorithm for transforming non-standardized OAR names used by treatment planners to standardized names defined by AAPM Task Group 263. This matching process primarily uses a table of synonyms that is updated as matches are made during use of the product, as well as a Natural Language Processing (NLP) model that attempts to match plan names not already in the synonym table. The NLP model selects the most likely match, which may be a correct match to a standard OAR name, an incorrect match, or no match (when the model considers this to be most likely, such as for names resembling a target). The user can also manually match names using a drop-down menu of all TG-263 OAR names. The user is instructed to check each automated match and make corrections using the drop-down menu as needed.

RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs. RayStation consists of multiple applications: - The main RayStation application is used for treatment planning. - The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems. The devices to be marketed, RayStation/RayPlan 2024A SP3, 2024A and 2023B, contain modified features compared to last cleared version RayStation 12A including: - Improved sliding window VMAT (Volumetric Modulated Arc Therapy) sequencing - Higher dose grid resolution for proton PBS (Pencil Beam Scanning) - Automated field in field planning - LET optimization (Linear Energy Transfer) These applications are built on a software platform, containing the radiotherapy domain model and providing GUI, optimization, dose calculation and storage services. The platform uses three Microsoft SQL databases for persistent storage of the patient, machine and clinic settings data. As a treatment planning system, RayStation aims to be an extensive software toolbox for generating and evaluating various types of radiotherapy treatment plans. RayStation supports a wide variety of radiotherapy treatment techniques and features an extensive range of tools for manual or semi-automatic treatment planning. The RayStation application is divided in modules, which are activated through licensing. A simplified license configuration of RayStation is marketed as RayPlan.