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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.

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.

ART-Plan+'s indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available. ART-Plan+'s includes several modules: - SmartPlan which allows automatic generation of radiotherapy treatment plan that the users import into their own Treatment Planning System (TPS) for the dose calculation, review and approval. This module is available for supported prescriptions for prostate only. - Annotate which allows automatic generation of contours for organs at risk, lymph nodes and tumors, based on medical practices, on medical images such as CT and MR images ART-Plan+ is not intended to be used for patients less than 18 years of age. The indicated users are trained medical professionals including, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists and medical professionals involved in the radiation therapy process. The indicated use environments include, but are not limited to, hospitals, clinics and any health facility offering radiation therapy.

ART-Plan+ is a software platform allowing contour regions of interest on 3D images and to provide an automatic treatment plan. It includes several modules: -Home: tasks -Annotate and TumorBox: contouring of regions of interest -SmartPlan: creation of an automatic treatment plan based on a planning CT and a RTSS -Administration and settings : preferences management, user account management, etc. -Institute Management: institute information, including licenses, list of users, etc. -About: information about the software and its use, as well as contact details. Annotate, TumorBox and SmartPlan are partially based on a batch mode, which allows the user to launch the operations of autocontouring and autoplanning without having to use the interface or the viewers. In that way, the software is completely integrated into the radiotherapy workflow and offer to the user a maximum of flexibility. ART-Plan+ offers deep-learning based automatic segmentation of OARs and LNs for the following localizations: -Head and neck (on CT images) -Thorax/breast (on CT images) -Abdomen (on CT and male on MR images) -Pelvis male (on CT and MR images) -Pelvis female (on CT images) -Brain (on CT images and MR images) ART-Plan+ offers deep-learning based automatic segmentation of targets for the following localizations: -Brain (on MR images)

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 XBeam Software can be used for validating the monitor units or radiation dose to a point that has been calculated by hand or another treatment planning system for external beam radiation therapy. In addition, the XBeam Software can also be used as a primary means of calculating the monitor units or radiation dose to a point for external beam radiation treatments. XBeam is only intended to be used with Xstrahl's superficial and orthovoltage radiotherapy and surface electronic brachytherapy systems. XBeam is intended to be used by authorized personnel trained in medical physics.

XBeam is a standalone dose calculation software for Xstrahl's medical devices include: - Xstrahl 100, Xstrahl 150, Xstrahl 200, Xstrahl 300 (K962613) - X80 RADiant Photoelectric Therapy System (K172080) - . RADiant Aura (X80 RADiant Photoelectric Therapy System) (K230611) XBeam's dose calculation algorithm can be used to determine the beam-on time or monitor units based on the applicator and filter selected for the specific device. The beam-on time / monitor units are calculated based on the percent dose depth (PDD) curve and the absolute dose output for the specified applicatorfilter combination. The software allows for calculating treatment parameters for single or two (parallel opposed) beams. XBeam is intended to be used within a clinical environment where the patient is treated with Xstrahl's medical systems. XBeam is intended to be used by authorized personnel trained in medical physics. It is not intended to be used by patients or general public.

Vitesse is indicated for use as a treatment planning software application used by medical professionals to plan,guide,optimize and document high-dose-rate brachytherapy procedures

The Varian VITESSE 5.0 is a stand-alone application which provides treatment planning features for high dose rate brachytherapy. Vitesse supports real-time ultrasound guided implant procedures as well as image import based workflows based on DICOM RT. Vitesse supports DICOM RT export of the plan to another external dose planning system (e.g., Brachy Vision) or directly to the brachytherapy afterloader treatment unit.

TrueFit/TrueFlex Bolus is indicated for and intended to be placed on the patient's skin as an accessory to attenuate and/or compensate the external beam (photon or electron) radiation during the treatment of various types of cancer. The device is for a single patient's use only and can be reused throughout the entirety of the treatment course. The device is designed by the radiation therapy professional using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use. The device is restricted to sale by on the order of a physician and is by prescription only.

TrueFit/TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. Patient imaging data from the treatment planning system (TPS) are used as inputs to generate digital design of the radiation therapy bolus (TrueFlex) by 3D Bolus Software Application (K213438), previously developed by Adaptiv. The resulting output Stereolithography (STL) file is compatible with the third-party 3D printers. A TrueFit Bolus is 3D printed by MJF technology using polyamide or polyurethane material. A Final TrueFlex Bolus device is manufactured by filling a mould with silicone. The bolus is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The bolus acts as a tissue-equivalent material placed on the patient skin to account for the buildup region of the treatment beam.