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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.

Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets. It is not intended for diagnostic purposes. Brainlab Elements Image Fusion is indicated for planning of cranial and extracranial surgical treatments and preplanning of cranial and extracranial radiotherapy treatments. Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. It is not intended for diagnostic purposes. Brainlab Elements Image Fusion Angio is indicated for planning of cranial surgical treatments and preplanning of cranial radiotherapy treatments. Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Weighted Imaging (DWI) data for use in treatment planning procedures. It is not intended for diagnostic purposes. Brainlab Elements Fibertracking is indicated for planning of cranial surgical treatments and preplanning of cranial radiotherapy treatments. Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. It is not intended for diagnostic purposes. Brainlab Elements Contouring is indicated for planning of cranial and extracranial surgical treatments and preplanning of cranial and extracranial radiotherapy treatments. Brainlab Elements BOLD MRI Mapping provides tools to analyze blood oxygen level dependent data (BOLD MRI Data) to visualize the activation signal. It is not intended for diagnostic purposes. Brainlab Elements BOLD MRI Mapping is indicated for planning of cranial surgical treatments.

The Brainlab Elements are applications and background services for processing of medical images including functionalities such as data transfer, image co-registration, image segmentation, contouring and other image processing. They consist of the following software applications: 1. Image Fusion 5.0 2. Image Fusion Angio 1.0 3. Contouring 5.0 4. BOLD MRI Mapping 1.0 5. Fibertracking 3.0 This device is a successor of the Predicate Device Brainlab Elements 6.0 (K223106). Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. It allows co-registration of 2D digital subtraction angiography images to 3D vascular images in order to combine flow and location information. In particular, 2D DSA (digital subtraction angiography) sequences can be fused to MRA, CTA and 3D DSA sequences. Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. The output is saved as 3D DICOM segmentation object and can be used for further processing and treatment planning. BOLD MRI Mapping provides methods to analyze task-based (block-design) functional magnet resonance images (fMRI). It provides a user interface with tools and views in order to visualize activation maps and generate 3D objects that can be used for further treatment planning. Brainlab Elements Fibertracking is an application for the processing and visualization of information based upon Diffusion Weighted Imaging (DWI) data, i.e. to calculate and visualize cranial white matter tracts in selected regions of interest, which can be used for treatment planning procedures.

TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software. The software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.

TraumaCad Neo 1.1 allows surgeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitates a film-less orthopedic practice. TraumaCad Neo 1.1 also allows post-operative review and assessment of X-ray images obtained after the surgical procedure, with a feature for automatic surgery outcome analysis of postoperative total hip arthroplasty images. The program features an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Neo supports DICOM and is communicating with Quentry®, a proprietary web-based cloud service from Brainlab and with other healthcare data platforms, such as PACS solutions. It is through these healthcare data platforms, where the medical staff can upload images to plan their expected results prior to the procedure to create a smooth surgical workflow from start to finish.

Mixed Reality Spine Navigation is an accessory to the Spine & Trauma Navigation Medical Device. The software is intended to display 2D navigation screens as well as a floating 3D virtual representation and stereotactic information of tracked instruments on a virtual display using a Mixed Reality headset. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The Subject device Mixed Reality Spine Navigation is an accessory to the Spine & Trauma Navigation System. It consists of the software Mixed Reality Spine Navigation 1.0 and the mixed reality headset Magic Leap 2 Medtech (ML2). The software application allows the display in the mixed reality headset of 2D navigation views and a 3D hovering model of the patient anatomy, including stereotactic information of tracked instruments to support the surgeon during pedicle screw placement procedures. The software Mixed Reality Spine Navigation is installed and running on the Magic Leap 2 MedTech glasses and can only be used in combination with a Brainlab Image Guided Surgery (IGS) platform (Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation Ceiling-Mounted), where the Spine & Trauma Navigation software is running. All required navigation data, such as the patient registration, is transferred over Wi-Fi from the IGS platform to the Magic Leap 2 MedTech. Based on these data, 2D views and a 3D model are rendered by the computing unit of the Magic Leap 2 MedTech and displayed stereoscopically in the headset. Thus, navigation information displayed on the screen(s) of the IGS platform can be simultaneously displayed on Magic Leap 2 MedTech during the surgery. Magic Leap 2 MedTech is an optical see-through head-mounted display: images are projected on semi-transparent optical layers, giving the surgeons the possibility to have virtual content displayed around the patient while having a view of the real world. If needed, corrective lenses can be attached to the headset.

The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. If the device is being used without the CSTS Integrated Plate, supplemental fixation must be used.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of heights, footprints, and lordotic angles. The CSTS Integrated Plates come in multiple heights and orientations to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the Integrated Plates into adjacent vertebral bodies for bony fixation. The Integrated Plates have a rotating locking tab to prevent back-out of the screws.

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.

LARALAB enables visualization, assessment and measurement of cardiovascular structures for: - Preprocedural planning and sizing for cardiovascular interventions and surgery - Postprocedural image review To facilitate the above, LARALAB provides general functionality such as: - Automatic segmentation of cardiovascular structures and other objects of interest (calcifications) - Automatic measurements - Manual measurement and adjustment tools - Visualization and image reconstruction techniques: Multiplanar Reconstruction (MPR), Surface rendering - Reporting tools

LARALAB is a stand-alone software developed to enable cardiologists, radiologists, heart surgeons and healthcare professionals ("Users") to import, view and process Medical Images. In particular, the software generates pre-calculated automatic segmentations and measurements based on deterministic Deep Learning Algorithms. Based on the output of the Deep Learning Algorithms, the User is able to further visualize, assess and measure ("Case Planning") various anatomical structures of the heart in the context of cardiovascular procedures (e.g., TAVR) such as heart valves, heart chambers, cardiac tissue and vessels, as well as such vessels and tissue relevant as access routes.

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.