Brainlab Elements Contouring (5.0)
by Brainlab AG
· Based in Germany →
— Innovating Medtech for Better Patient Outcomes
Contact for pricing
Regulatory Status Disclosed
Overview
Brainlab Elements Contouring (5.0) is a core component of the Brainlab Elements suite, a comprehensive set of software applications designed to enhance image-guided surgery and radiation treatment planning. This AI-powered tool provides an intuitive interface with advanced functionalities for outlining, editing, refining, combining, and manipulating structures within patient image data, ultimately generating precise 3D DICOM segmentation objects. It is indicated for planning a wide range of cranial and extracranial surgical treatments and for the preplanning of cranial and extracranial radiotherapy treatments. The software streamlines workflows through automated contouring processes, robust image fusion capabilities, and can integrate with external AI-powered segmentation tools to further boost efficiency and consistency in treatment planning. Engineered for multi-disciplinary use, Brainlab Elements Contouring (5.0) supports clinical specialties including neurosurgery, spine surgery, orthopedics, and radiation oncology, offering multi-platform flexibility for deployment on workstations and mobile devices.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Intuitive interface for outlining, editing, refining, combining, and manipulating structures in patient image data
- Generates 3D DICOM segmentation objects for further processing and treatment planning
- Automated contouring process, including knowledge-based anatomical atlas segmentation
- Advanced image fusion capabilities (rigid and deformable registration) across various modalities (CT, MRI, PET, SPECT, US, DSA)
- Visualization of neurological and vascular structures, with dynamic color-coded contrast flow projections
- Supports image-guided surgery and radiation treatment planning workflows
- Integration with AI-powered segmentation tools for cranial and extracranial structures, including organs at risk (OAR) and tumors
- Multi-platform flexibility, supporting use on workstations, iPad, and iPhone
- Integrated DICOM Viewer for streamlined access to patient data sets
- Provides volumetric reports for tumor monitoring, including measurements like MacDonald criteria
Use Cases
- Planning cranial and extracranial surgical treatments
- Preplanning cranial and extracranial radiotherapy treatments
- Image-guided neurosurgery, spine surgery, orthopedics, and radiation oncology
- Stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) planning for brain metastases, arteriovenous malformations (AVMs), and spine tumors
- Optimizing visualization and identification of intracranial vascular structures for surgical and radiosurgical planning
- Reducing inter-clinician variability and improving efficiency in radiation therapy planning
What Physicians Need to Know
Key Capabilities
Brainlab Elements Contouring 5.0 provides an interface with tools for outlining, editing, refining, combining, and manipulating structures in patient image data. It includes modules for 2D and 3D image viewing, processing, co-registration, segmentation, and 3D visualization for treatment planning. The software offers automatic segmentation of cranial tumors using machine learning algorithms. It features automated anatomical mapping of cranial MR datasets with thorough tissue classification and efficient, consistent automation of contouring processes. SmartBrush Angio functionality enhances visualization and identification of arteriovenous malformation (AVM) nidus by fusing diagnostic DSA with volumetric MRI and CT images. It also supports stereotaxy use cases such as Deep Brain Stimulation (DBS), stereo-electroencephalography (sEEG), and biopsies, with advanced segmentation tools and white matter tractography.
Clinical Utility
This tool is indicated for processing medical image data to support image-guided surgery and radiation treatment planning. It is specifically used for planning cranial and extracranial surgical treatments and preplanning of cranial and extracranial radiotherapy treatments. The software enhances pre-surgical planning and radiotherapy by enabling clinicians to precisely distinguish anatomical structures, such as arteries and veins from an AVM nidus, which can reduce the final target size for stereotactic radiosurgery. It can eliminate the need for additional planning digital subtraction angiography (DSA) in AVM cases, reducing patient discomfort and risks. Brainlab Elements Contouring 5.0 provides precision and control for accurate trajectory planning in functional neurosurgery.
Integration Options
Brainlab Elements Contouring 5.0 integrates into the surgeon's chosen delivery platform. It is part of the broader Brainlab Elements suite, which includes applications like Image Fusion, Fibertracking, and BOLD MRI Mapping. The output is saved as a 3D DICOM segmentation object, facilitating further processing and integration into other treatment planning systems. The software supports collaboration through Quentryu00ae for departmental, cross-functional, and external expert consultations. It offers multi-platform flexibility, allowing clinicians to work online on various devices, including iPads and iPhones, or offline on workstations. It also works with Brainlab platforms such as Curveu00ae Navigation, Kicku00ae, Loop-X* Mobile Imaging Robot, and Buzzu00ae Digital O.R.
Compliance Status
Brainlab Elements Contouring 5.0 is a Class II medical device and has received FDA 510(k) clearance (K243633 for version 5.0, K223106 for version 4.5). It must comply with FDA regulations, including registration and listing (21 CFR Part 807), labeling (21 CFR Part 801), medical device reporting (21 CFR Part 803), and good manufacturing practices (21 CFR Part 820). The device is not intended for diagnostic purposes but rather for processing medical image data to support treatment planning.
Pricing Model
Brainlab offers flexible and scalable business models for its Elements suite, allowing facilities to access the software according to their needs and departmental size.
User Experience
The software features intuitive user interfaces and automated workflows, designed for a user-focused experience in both straightforward and complex clinical cases. It streamlines the pre-planning workflow into automated steps for merging, contouring, and viewing, operable with touch or mouse/keyboard control. Multi-platform flexibility, including access on mobile devices like iPads and iPhones, allows for easy planning and review for busy clinicians.
Support Quality
Brainlab provides timely access to technical support for its Elements software suite.
Implementation Complexity
Effective operation of Brainlab Elements Contouring 5.0 requires a computing environment that meets specific hardware criteria and trained personnel to correctly interpret and utilize the processed images.
Evidence Base
Clinical validation has demonstrated the software's effectiveness in pre-planning for surgeries and radiotherapy, meeting safety and performance requirements through rigorous verification and validation processes. Studies indicate that newer versions of Brainlab Elements can automatically generate Stereotactic Radiosurgery (SRS) plans with comparable quality to manually optimized plans, in a shorter time and with less planner involvement. Research has also evaluated the accuracy of its automatic segmentation, for instance, in Deep Brain Stimulation planning. Clinical use cases, such as AVM radiosurgery planning, highlight its ability to improve target definition and reduce treatment risks.
Physician Tip
Leverage the automated contouring and segmentation features to significantly reduce planning time, especially for cranial tumors and complex AVM cases. Utilize the multi-modality image fusion capabilities to gain a comprehensive understanding of patient anatomy and pathology, enhancing precision in surgical and radiotherapy planning. Take advantage of the mobile access for flexible planning and review, allowing for efficient workflow management even outside the main workstation. Remember that while the AI assists in contouring, physician review and adjustment remain crucial for optimal patient-specific treatment plans.
Brainlab Elements Contouring 5.0 is designed to be a core component within the Brainlab ecosystem, seamlessly integrating with other Elements applications like Image Fusion and Fibertracking. Its output in 3D DICOM segmentation format ensures compatibility with various downstream treatment planning and navigation systems. The multi-platform support, including mobile devices, facilitates integration into diverse clinical IT environments and workflows.
Details
| Category | Oncology AI, Radiology & Imaging AI, Surgical AI |
| Pricing | Contact for pricing — Pricing is not publicly disclosed and may vary by country and specific configuration. |
| Deployment | On-premise (workstation) with cloud-based services for image storage and AI-powered segmentation integration. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Brainlab Elements Contouring (5.0) is part of the Brainlab Elements (7.0) suite, which received FDA clearance under K243633 on June 13, 2025. It is indicated for planning cranial and extracranial surgical treatments and preplanning cranial and extracranial radiotherapy treatments, providing tools to outline, refine, combine, and manipulate structures in patient image data, with output saved as 3D DICOM segmentation objects. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Oncology, Radiology |
What the Web Says
Brainlab Elements Contouring 5.0 is a medical imaging software application designed to assist clinicians in planning cranial and extracranial surgical and radiotherapy treatments. It provides tools for outlining, refining, combining, and manipulating anatomical structures in patient image data, generating 3D DICOM segmentation objects for further processing and treatment planning. The software is part of the broader Brainlab Elements suite, which aims to streamline pre-planning workflows and enhance precision in image-guided procedures.
Overall: PositiveStrengths
- Streamlines pre-planning workflow with intuitive modules for automation, merging, contouring, and viewing.
- Offers advanced tools like atlas segmentation for automated anatomical labeling and SmartBrush for intelligent tumor outlining.
- Supports collaboration across departments and locations with multi-platform flexibility, including mobile devices.
- Enhances workflow efficiency and reduces error potential through integration with other Brainlab platforms.
- Demonstrates effectiveness in pre-planning for surgeries and radiotherapy through clinical validation.
- Can significantly reduce planning time, making advanced treatments more accessible.
Limitations
- Requires proper hardware and user expertise for effective operation.
- AI features are dependent on input image quality and user-defined parameters.
- Not intended for diagnostic purposes.
- The software assists but does not replace the critical decision-making of human surgeons.
Based on reviews from: FDA Radiology AI Device, accessdata.fda.gov, Medical News Observer, PDF Catalogs | Technical Documentation, YouTube, Frontiers, PMC
Last updated: 2026-07-18
Ratings & Reviews
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Press & Coverage
FDA Radiology AI Device
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | FDA Radiology AI Device
Brainlab Elements are software applications for processing medical image data to support image-guided surgery and radiation treatment planning, incorporating AI for tumor segmentation. The suite includes modules for 2D/3D image viewing, processing, co-registration, segmentation, and 3D visualization.
2023-07
FDA
K243633 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification details the clearance of Brainlab Elements (7.0), which includes Brainlab Elements Contouring (5.0), among other modules. The document lists Brainlab AG as the applicant and provides regulatory information for the device.
2025-06
FDA Radiology AI Device
Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | FDA Radiology AI Device
This entry describes the Brainlab Elements software suite, including Contouring (5.0), which provides tools for image fusion, angiographic image registration, contouring, fibertracking, and functional MRI mapping for precise treatment planning. The software supports combining and analyzing various imaging data to visualize critical anatomical and functional areas.
2025-06
accessdata.fda.gov
June 13, 2025 Brainlab AG Sadwini Suresh QM Consultant Olof-Palme-Str.9 Munich, 81829 Germany Re: K243633 Trade/Device Name - accessdata.fda.gov
This FDA document confirms the 510(k) premarket notification for Brainlab Elements Contouring (5.0), indicating its use for outlining, refining, combining, and manipulating structures in patient image data for surgical and radiotherapy treatment planning. It specifies that the output is saved as a 3D DICOM segmentation object for further processing.
2025-06
Innolitics
QIH u00b7 Automated Radiological Image Processing Software u2014 FDA Product Code | Innolitics
Innolitics lists Brainlab Elements Contouring (5.0) under the FDA product code QIH for Automated Radiological Image Processing Software, noting its clearance in June 2025. This product code encompasses software implementing artificial intelligence, including nonadaptive machine learning algorithms, for image processing and analysis.
2025-06
Brainlab
CE marking - Brainlab
Brainlab's official CE marking page confirms that Brainlab Elements Contouring 5.0 has received CE 0123 certification from Tu00dcV Su00dcD Product Service GmbH. This indicates compliance with European health, safety, and environmental protection standards.
unknown
Anvisa
INSTRUu00c7u00d5ES DE USO - Anvisa
This instruction for use document from Anvisa, the Brazilian Health Regulatory Agency, lists Brainlab Elements Contouring 5.0 as a compatible software. It outlines cybersecurity vulnerabilities and the hospital's responsibility to limit access to the system and patient data.
2025-06
FDA.report
BRAINLAB, INC. FDA Filings - FDA.report
FDA.report lists Brainlab Elements Contouring (5.0) as part of Brainlab AG's FDA filings, with a clearance date of June 13, 2025. This entry provides an overview of Brainlab's various FDA-cleared devices and their respective dates.
2025-06
Videos
Product demos, reviews, and walkthroughs for Brainlab Elements Contouring (5.0).
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Frequently Asked Questions
Brainlab Elements Contouring 5.0 is designed as a software application suite for processing medical image data, facilitating image-guided surgery and radiation treatment planning. It integrates by providing modules for image viewing, co-registration, segmentation, and 3D visualization, with outputs saved as standard 3D DICOM segmentation objects for seamless use in downstream treatment planning. This streamlines the pre-planning workflow by automating, merging, contouring, and viewing data, aiming to reduce manual effort and time.
Physician oversight and validation are crucial, as the system provides assistance and does not replace the surgeon's experience or responsibility. Users are expected to review, adjust, or reject automatically segmented tumor objects and other contours. Before patient treatment, it is mandatory to review the plausibility of all information generated by the system.
Brainlab Elements Contouring 5.0 is part of the Brainlab Elements 7.0 suite, which holds FDA clearance as a Class II medical device. Brainlab ensures patient data privacy and security through HIPAA and GDPR compliance, employing dedicated officers and personnel responsible for these regulations. Data is encrypted during transmission and storage using AES 256-bit encryption, and stored in secure, certified data centers, with options for pseudonymization of patient information.
Brainlab Elements Contouring 5.0 significantly enhances efficiency by reducing manual delineation time, with studies showing substantial time savings for contouring organs at risk. In terms of accuracy, clinical validation demonstrates its effectiveness in pre-planning, with automatic segmentations for structures like the subthalamic nucleus showing comparable accuracy to research tools and falling within the range of interrater variability. Geometric analysis of contours for brain tumors has shown high Dice Similarity Coefficient values, indicating strong agreement with manual contours.
Specific pricing details for Brainlab Elements Contouring 5.0 are not publicly disclosed and typically require direct consultation with Brainlab. However, Brainlab generally offers flexible business models that are scalable to the evolving needs of different departments and facilities. This suggests that various licensing or subscription options may be available depending on the scope of use.
The primary limitations of Brainlab Elements Contouring 5.0 include its reliance on appropriate hardware, user expertise, and the quality of input images. While it supports cranial, head and neck, and extracranial lesions, complex or unusual anatomies, or cases with significant post-surgical changes, may require more intensive manual correction and validation. The system provides tools for review and editing to address these scenarios.
Potential risks of relying on AI for contouring include the possibility of variability or errors that could lead to suboptimal treatment plans, especially with small positioning errors in complex treatments. Brainlab Elements Contouring 5.0 mitigates these risks by functioning as an assistive tool that requires mandatory physician review and validation of all AI-generated contours. The software undergoes rigorous verification and validation processes, and Brainlab recommends user training to ensure safe and appropriate application.
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| Last Verified: 2026-04-17 | First Added: 2026-04-17