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Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.

Leksell GammaPlan® is a powerful, computer-based treatment planning system specifically designed for the simulation and planning of stereotactic Leksell Gamma Knife® radiosurgery based on tomographic and projectional images. The basis of treatment planning is the acquisition and processing of digital images by a computer workstation running the treatment planning application software. The program is capable of handling a range of different imaging modalities. Images from tomographic sources such as Computer Tomography (CT), Magnetic Resonance (MR) and Positron Emission Tomography (PET) scanners can be used as well as projectional images from angiograms (AI). This allows the direct comparison between vascular structures in projectional images and tissue structures in CT and MR. Digital images can be imported into the system via the computer network. The treatment planning application has the ability to plan a patient's treatment protocol based on a single target or multiple targets. The basic elements of treatment planning are: - defining the cranial target or targets . - . devising the configuration of the collimators to be used during treatment - determining the parameters of the radiation shots to be delivered by Leksell • Gamma Knife®.

Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT). The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician the images acquired before, during, and after the radiotherapy treatment vield information that can be useful in diagnosis and may assist therapy planning, patient positioning, and treatment delivery related to radiation oncology. In addition to the motion monitoring with manual interrupt previously cleared with predicate Unity devices, the subject device Elekta Unity has added the following motion management strategies: - · Anatomic Position Monitoring (APM) with Manual interrupt (also referred to as True Tracking as it 'tracks' in 3D and enables the system to gate using the 3D position of the anatomy's motion) - · APM with Anatomic Tolerance Check (ATC) - Adaptive Therapy with optional Baseline Shift (BLS) Recovery. These modifications are not contained solely within the Elekta Unity Device, as the full clinical benefit is achieved with interoperability of Unity, Monaco RTP, and MOSAIQ OIS.

MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. Medical oncology dose calculations are designed to support both adult and pediatric patients. It lets users: - · Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications. - · Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology. - · Import, view, annotate, adjust, enhance, manage and archive images. - · Compare radiation treatment plans and evaluate dose coverage. - · Design leaf plans for operation with radiotherapy treatment machines that have multi-leaf collimators. - · Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user. - · View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup and communicates patient and machine setup instructions. - · Record actual delivered radiation values in an electronic chart to track treatment. - · Use stereotactic localization to calculate set-up coordinates for treatments. - · Monitor Intrafractional motion with real time image overlay. MOSAIQ® is not intended for use in diagnosis.

The MOSAIQ® Oncology Information System (OIS) is an image-enabled electronic medical record system. It manages clinical and administrative workflows within oncology departments and facilitates efficient patient care. It can be configured for Medical Oncology, Radiation Oncology, or both. The Medical Oncology (MO) configuration is a medical oncology charting solution that includes customizable regimens (Care Plans) that automate chemotherapy orders for labs, procedures, and appointments. Configurable flowsheet views are used for reviewing treatment administration, documents, assessment and lab data. Users can enter medications and screen for drug/drug and drug/allergy interactions. MOSAIQ also performs standard calculations such as Body Surface Area (BSA) and Area Under the Curve (AUC). The Medical Administration Record (MAR) supports all information related to chemotherapy and blood product administration, clinical trial study drugs, dose amounts, infusion time, multiple administration, etc. The Radiation Oncology configuration is also a charting solution with Computerized Physician Order Entry (CPOE) capability, along with added features for image management, patient setup and positioning, verify and record, plan import, review, and approval, stereotactic localization, and pretreatment checks. MOSAIQ's Radiation Oncology functionality can be used to support a wide variety of treatment modalities including Intensity Modulated Radio Therapy (IMRT), Image Guided Radio Therapy (IGRT), particle therapy, and stereotactic radiotherapy. It can import and store treatment plans from Therapy Planning Systems (TPS) via DICOM import/DICOM RT import. In addition to these, the current version of MOSAIQ introduces the following modifications for radiation oncology: - · Anatomic Position Monitoring (APM) with Manual interrupt (also referred to as True Tracking as it 'tracks' in 3D and enables the system to gate using the 3D position of the anatomy's motion) - · APM with Anatomic Tolerance Check (ATC) - · Adaptive Therapy with optional Baseline Shift (BLS) Recoverv - · Care Rules for motion management. These modifications are not contained solely within MOSAIQ, as the full clinical benefit is achieved with interoperability of Unity, Monaco RTP, and MOSAIQ OIS.

The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and proton treatment plans and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: - contouring - image manipulation - simulation - image fusion - plan optimization - QA and plan review

The Monaco RTP System accepts patient diagnostic imaging data from CT and MR scans, and source dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation, on these diagnostic images. Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a beam modifier (MLC, block, etc.) between the source of radiation and the patient to shape the beam. Monaco RTP system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The optimal plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes. The parameters of the plan are output for later reference and for inclusion in the patient file. Monaco planning methods and modalities: - Intensity Modulated Radiation Treatment (IMRT) planning - Electron, photon and proton treatment planning - Planning for dynamic delivery methods (e.g. dMLC, dynamic conformal, Volumetric Modulated Arc Therapy (VMAT)) - Stereotactic planning and support of cone-based stereotactic - 3D conformal planning - Adaptive planning (e.g. for the Elekta Unity MR-Linac) - Monaco basic systems tools, characteristics, and functions: - Plan review tools - Manual and automated contouring tools - DICOM connectivity - Windows operating system - Simulation - Support for a variety of beam modifiers (e.g. MLCs, blocks, etc.) - Standardized uptake value (SUV) - Specialty Image Creation (MIP, MinIP, and Avg) - Monaco dose and Monitor Unit (MU) calculation: - Dose calculation algorithms for electron, photon, proton planning Monaco is programmed using C and C++ computer programming languages. Monaco runs on Windows operating system and off-the-shelf computer server/hardware.

Leksell Gamma Knife® is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. - · Metastatic tumors - Recurrent glioblastomas - · Trigeminal neuralgia - · Medically refractory essential tremor - · Orbital tumors - · Ocular tumors - · Optic nerve tumors · Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, chordomas, chordomas, glomus tumors, hemangiomas) - · Skull base tumors · Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, - nasopharynx, sinonasal, salivary gland) · Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, skull base tumors)

Leksell Gamma Knife® (available models Icon™, Perfexion™ and Elekta Esprit) is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and proton treatment plans and displays, on-screen and in hard-copy, two- or threedimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: - contouring - image manipulation - simulation - image fusion - . plan optimization - QA and plan review

The Monaco RTP System accepts patient diagnostic imaging data from CT and MR scans, and source dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation, on these diagnostic images. Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a beam modifier (MLC, block, etc.) between the source of radiation and the patient to shape the beam. Monaco RTP system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The optimal plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes. The parameters of the plan are output for later reference and for inclusion in the patient file. Monaco planning methods and modalities: - Intensity Modulated Radiation Treatment (IMRT) planning . - . Electron, photon and proton treatment planning - . Planning for dynamic delivery methods (e.g. dMLC, dynamic conformal, Volumetric Modulated Arc Therapy (VMAT)) - . Stereotactic planning and support of cone-based stereotactic - . 3D conformal planning - . Adaptive planning (e.g. for the Elekta Unity MR-Linac) Monaco basic systems tools, characteristics, and functions: - . Plan review tools - . Manual and automated contouring tools - DICOM connectivity . - . Windows operating system - . Simulation - . Support for a variety of beam modifiers (e.g. MLCs, blocks, etc.) - . Standardized uptake value (SUV) - Specialty Image Creation (MIP, MinIP, and Avq) • - . Monaco dose and Monitor Unit (MU) calculation: - Dose calculation algorithms for electron, photon, proton planning . Monaco is programmed using C and C++ computer programming languages. Monaco runs on Windows operating system and off-the-shelf computer server/hardware.

AATMA™ is a medical image processing library intended to produce derived data sets for use as input into radiation therapy treatment planning systems or other intermediate pre-treatment-planning applications. AATMA™ does not provide a user interface and is designed to be accessed through its application programming interface (API) by other devices. The data sets created by AATMA™ must be reviewed and validated by a qualified healthcare professional prior to clinical use.

AATMA™ is an optional accessory to treatment planning systems and intermediate pre-treatment planning applications. The auto-segmentation algorithm in AATMA™ is based on machine-learning convolutional neural networks and includes pre-trained models that will be used to automatically segment image sets. The algorithm itself functions as a computational engine and does not store any input data, output data, or logs. The available models have been pre-trained on specific datasets that exhibit similar characteristics (e.g., body site and imaging modality). As a medical image processing library, AATMA™ is designed to produce derived datasets in standard formats (e.g., DICOM) that can be utilized by other applications. AATMA™ does not have a user interface and, as such, calling applications must execute the auto-segmentation algorithms via AATMA™'s application programming interface (API). AATMA™ must be used in conjunction with appropriate software to review and edit results generated automatically by the auto-segmentation algorithm. A pre-treatment planning system or treatment planning system must be used to facilitate the review and edit of contours generated by the auto-segmentation algorithm within AATMA™.

Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT). The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician the images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology. In addition to the MRI sequences cleared with the predicate device, the subject device Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment: Introduce 3D Vane 3D Vane XD is a free breathing acquisition method that can be used to compensate for respiratory motion and peristalsis in 3D/FFE and 3D/TFE body imaging. Introduce CS-Sense - compressed images Compressed SENSE is an acceleration technique that is less sensitive to noise allowing increased resolution and/or coverage without a scan time penalty. Introduce Breath Hold (BH) . Breath-hold is a technique where an image is acquired when a patient holds their breath in a defined phase of the breathing cycle.

The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, proton, and electron treatment plans and displays, on-screen and in hard-copy, two- or threedimensional radiation dose distributions inside patients for given treatment plan setups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: - · contouring - · image manipulation - · simulation - · image fusion - · plan optimization - QA and plan review

Monaco is a radiation treatment planning system that first received FDA clearance in 2007 (K071938). The modified system received clearance in 2009. when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091179), again when Dynamic Conformal Arc planning was added (K110730), and electron planning, support for stereotactic cones, and SUV calculation were added (K132971). Specialty image creation was added in 2015 (K151233), and adaptive planning and dose calculation in the presence of a magnetic field (e.g., MR-Linac) was added in 2018 (K183037). A 510(k) was filed in 2017 for the addition of carbon ion planning. The 510(k) was withdrawn because there was no hardware cleared for the US market capable of delivering carbon ion plans. Monaco's carbon ion planning functionality remains licensed off and inaccessible to US users. The Monaco system accepts patient imaging data and "source" dosimetry data from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation on these diagnostic images. Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a beam modifier (MLC, block, etc.) between the source of radiation and the patient to shape the beam. The Monaco system then produces a display of radiation dose distribution within the patient, indicating doses to the target volume and surrounding structures. The "best" plan satisfying the clinican prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes. Monaco 6.00 supports Proton Pencil Beam Scanning (Proton PBS) planning for IBA Proteus®ONE and Proteus®PLUS delivery systems (Ion Beam Applications S.A.).