Brainlab Elements Image Fusion (5.0)

by Brainlab AG  · Based in Germany → — Advanced Image Fusion for Precise Surgical and Radiotherapy Planning
Neurosurgery Oncology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

Brainlab Elements Image Fusion (5.0) is a sophisticated software application within the Brainlab Elements suite, designed for the co-registration and alignment of various medical image data sets. It utilizes rigid and deformable registration methods to accurately align anatomical structures, providing clinicians with enhanced insights for treatment planning. [13, 15, 21] This tool is integral to both cranial and extracranial surgical and radiotherapy planning, enabling the fusion of different image modalities such as MRA, CTA, DSA, MRI, and intraoperative CT (iCT). [13, 15, 16, 21, 24]

The software facilitates the integration of preoperative planning data into intraoperative scenarios, supporting precise navigation and visualization of patient anatomy. [16] It allows for region-of-interest definition for targeted data correlation and offers flexibility in contouring on various datasets. [25, 30] While not intended for diagnostic purposes, Brainlab Elements Image Fusion 5.0 plays a crucial role in improving the accuracy and consistency of medical treatments by providing a comprehensive and integrated view of patient data. [15, 21]

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Fully automated and highly accurate image fusion
  • Rigid and deformable registration methods
  • Co-registration of multiple image modalities (MRA, CTA, DSA, MRI, iCT)
  • Region-of-interest (ROI) definition for targeted correlation
  • Flexibility to contour on any datasets
  • Integration with other Brainlab Elements modules (e.g., Contouring, Fibertracking, BOLD MRI Mapping)
  • Support for intraoperative image updates (e.g., Ultrasound Snap to MRI)
  • Advanced 2D and 3D visualization
  • AI features for identification of previously diagnosed lesions or tumors (in Elements Image Fusion Angio, part of the cleared suite)
  • Streamlined pre-planning workflow

Use Cases

  • Cranial and extracranial surgical planning
  • Pre-planning for radiotherapy treatments
  • Functional neurosurgery (e.g., Deep Brain Stimulation, sEEG, biopsies)
  • Intraoperative navigation updates with real-time imaging
  • Spine surgery planning and navigation
  • Pre-planning for tumor resection and assessment

What Physicians Need to Know

Key Capabilities
Brainlab Elements Image Fusion (5.0) offers fast, automatic, and highly accurate co-registration of medical image data from various modalities (CT, MRI, PET, SPECT, US, 2D DSA to 3D vascular images) using rigid and deformable registration methods. It provides advanced 2D and 3D visualization, including stereoscopic 3D views for deeper anatomical insights, and supports region-of-interest (ROI) fusion and customized fusion order selection. The software also includes Elements Distortion Correction Cranial to improve the accuracy of tractography by correcting MRI distortion.
Clinical Utility
This tool significantly enhances pre-surgical planning for cranial and extracranial surgical treatments, as well as radiotherapy, by providing superior anatomical insights for vital structure definition and contouring. It aids in precise trajectory planning for procedures like Deep Brain Stimulation (DBS), sEEG, and biopsies. The system supports image-guided surgery, improving accuracy and safety by enabling real-time updates to navigation images to compensate for intraoperative brain shift. The Angio module specifically co-registers cerebrovascular image data, combining flow and location information for vascular procedures.
Integration Options
Brainlab Elements Image Fusion (5.0) is designed for seamless integration within clinical workflows. It transfers DICOM data to and from PACS and other storage media. The software integrates with Brainlab navigation systems (e.g., Curveu2122 Image Guided Surgery, Kicku00ae Purely Navigation) and a wide array of intraoperative imaging devices, including various 3D C-arms (Ziehm RFD 3D, GE OEC 3D, Siemens Cios Spin, Siemens Arcadis Orbic 3D) and the Airou00ae Mobile Intraoperative CT. It also supports integration with intraoperative ultrasound systems for automated rigid fusion and real-time anatomical updates. Furthermore, it is compatible with fully integrated navigation instruments from Brainlab and partners like DePuy Synthes and Aesculap.
Compliance Status
Brainlab Elements Image Fusion (5.0) has received FDA 510(k) clearance (K243633), demonstrating compliance with safety and performance standards. It is explicitly stated that the software is intended for aligning anatomical structures and processing medical image data to aid surgical interventions and treatment planning, but it is not intended for diagnostic purposes.
Pricing Model
Brainlab offers flexible business models for Elements, ranging from single licenses to multiple offerings across various departments. The cost typically includes a one-year licensing support agreement, with subsequent annual payments required for continued licensing and service contracts.
User Experience
The software is designed for a user-focused and intuitive experience, streamlining the pre-planning workflow with features like 'Automate, Merge, Contour, View' accessible via touch or mouse click. Its simplified multi-touch drag-and-drop user interface contributes to a rapid learning curve. The multi-platform flexibility allows users to access full software functionality on preferred devices, including iPads and iPhones, or offline on workstations, fitting into diverse clinical IT setups.
Support Quality
Brainlab provides timely access to technical support for its Elements suite. System updates are performed on-site by the vendor, ensuring continuous functionality and a positive customer experience.
Implementation Complexity
While designed for seamless integration with existing systems, effective operation requires a computing environment that meets specific hardware criteria and trained personnel to correctly interpret and utilize the processed images. The system is scalable to accommodate the evolving needs of various departments.
Evidence Base
Clinical validation has demonstrated the effectiveness of Brainlab Elements Image Fusion in pre-planning for surgeries and radiotherapy. The software has undergone rigorous verification and validation processes, proving its performance comparable to previous versions and similar market products. Its utility is supported by FDA 510(k) clearance and referenced in multiple clinical studies and publications for applications in neurosurgery, spine surgery, and radiotherapy planning, highlighting its role in enhancing preoperative assessment and surgical outcomes.
Physician Tip

Leverage Brainlab Elements Image Fusion (5.0) to enhance your pre-operative planning by fusing multi-modality images for a comprehensive anatomical overview, especially in complex cranial and spinal cases. Utilize the automatic co-registration and region-of-interest fusion for precise targeting and to minimize manual adjustments. Integrate intraoperative imaging (e.g., ultrasound) to dynamically update navigation and account for brain shift, thereby maintaining accuracy throughout the procedure. Remember that while the software is powerful for planning and guidance, it is not intended for primary diagnostic purposes.

Brainlab Elements Image Fusion (5.0) is highly interoperable, designed to integrate seamlessly with existing DICOM-compliant PACS, Brainlab navigation platforms, and a wide range of intraoperative imaging devices including 3D C-arms and mobile CT scanners. Its compatibility extends to various surgical instruments from Brainlab and partner manufacturers. Consider its multi-platform flexibility for accessing planning and review functionalities across different devices within your department's IT infrastructure.

Details

Category Oncology AI, Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing — Custom quotes available based on institutional needs and required modules.
DeploymentOn-premise (workstation) with cloud integration for data exchange
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Brainlab Elements (7.0), which includes Brainlab Elements Image Fusion (5.0), received FDA approval (K243633) on June 13, 2025. [15, 19, 21] It is cleared for applications in planning cranial and extracranial surgical and radiotherapy treatments, but not for diagnostic purposes. [15, 21]

Integrations
EHR Not specified
Specialties Neurosurgery, Oncology, Radiology

What the Web Says

Brainlab Elements Image Fusion (5.0) is a software application designed for co-registration of medical image data using rigid and deformable registration methods. It is part of the broader Brainlab Elements suite, which aims to assist in image-guided surgery and radiation treatment planning by transforming 2D medical scans into interactive 3D anatomical maps. The software is intended for use by medical professionals for planning cranial and extracranial surgical and radiotherapy treatments, not for direct diagnostic purposes.

Overall: Positive

Strengths

  • Automated, accurate co-registration of image modalities.
  • Provides better anatomical insights for definition and contouring.
  • Enhances pre-surgical planning and radiotherapy.
  • Supports collaboration across departments and on various devices.
  • Streamlines pre-planning workflow and reduces planning time.
  • Integrates with other Brainlab platforms for enhanced workflow efficiency.

Limitations

  • Dependency on proper hardware and user expertise for effective operation.
  • AI features depend heavily on input image quality and user-set parameters.
  • Not intended for direct diagnosis or creating physical replicas for diagnostic purposes.
  • Cost of Brainlab navigation systems can be high (though specific pricing for Image Fusion 5.0 is not available).
  • Limited information on specific user reviews from independent platforms like G2 or Capterra was found in the search results.
  • No specific contraindications for the software itself, but usage is limited to interpretation and manipulation of image data by medical professionals.

Based on reviews from: Medical News Observer, accessdata.fda.gov, Brainlab, Reddit, AuntMinnie

Last updated: 2026-07-17

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Press & Coverage

FDA
FDA K243633 - 510(k) Premarket Notification
This regulatory announcement details the FDA 510(k) clearance for Brainlab Elements (7.0), which includes Brainlab Elements Image Fusion (5.0), on June 13, 2025. The document outlines the intended use of the software for co-registration of image data in medical procedures using rigid and deformable registration methods.
2025-06
RadAI
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 article from RadAI's FDA Radiology AI Device database highlights the FDA approval of Brainlab Elements 7.0, including Image Fusion 5.0, on June 13, 2025. It describes the software's capabilities for image fusion, angiographic image registration, contouring, fibertracking, and functional MRI mapping to support precise treatment planning.
2025-06
RadAI
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
This entry from RadAI details the Brainlab Elements suite, including Image Fusion, as software applications for processing medical image data to support image-guided surgery and radiation treatment planning. It mentions the incorporation of AI via a convolutional neural network for tumor segmentation.
2023-07
Brainlab
CE marking - Brainlab
Brainlab's official CE marking page lists Brainlab Elements Image Fusion 5.0 as having 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 document from Anvisa, the Brazilian Health Regulatory Agency, includes Brainlab Elements Image Fusion 5.0 in its instructions for use, indicating its regulatory approval for use in Brazil. It also lists compatible software and devices.
2025-06
Innolitics
QIH u00b7 Automated Radiological Image Processing Software u2014 FDA Product Code | Innolitics
This Innolitics page, which categorizes FDA product codes, lists Brainlab Elements (7.0) and Brainlab Elements Image Fusion (5.0) under the QIH product code for Automated Radiological Image Processing Software, with a clearance date of June 13, 2025.
2025-06

Videos

Product demos, reviews, and walkthroughs for Brainlab Elements Image Fusion (5.0).

View all on YouTube

Frequently Asked Questions

Brainlab Elements Image Fusion 5.0 utilizes rigid and deformable registration methods for precise co-registration of various image modalities, aiding in the alignment of anatomical structures for surgical and radiotherapy planning. While specific AI features for image fusion in version 5.0 are part of an evolving suite, Brainlab integrates AI and machine learning to enhance automated features, improve planning accuracy, and streamline workflows across its Elements portfolio.
Yes, Brainlab Elements Image Fusion (5.0) received FDA 510(k) clearance (K243633) as a Class II medical device, indicating its safety and effectiveness for its intended use. For data privacy, Brainlab Cloud Services, often used with Elements, are HIPAA compliant, storing patient data on regional servers (US for US users, EU for EU users) and employing AES 256-bit encryption for data at rest and in transit.
The primary limitations include a dependency on proper hardware and user expertise, requiring trained personnel and a suitable computing environment for optimal performance. Furthermore, the AI's effectiveness is highly reliant on the quality of the input images and the parameters set by the user, and it is not intended for direct diagnosis.
While direct, identically featured AI-powered image fusion alternatives for surgical planning are not extensively detailed in general searches, other companies offer medical image management and processing systems or image-guided surgery platforms. Fujifilm, for instance, has its Synapseu00ae Enterprise Imaging portfolio with an AI initiative (REiLIu00ae) that focuses on advanced imaging and AI.
Brainlab typically offers flexible business models, ranging from single licenses to comprehensive departmental offerings. Pricing often includes a one-year licensing support agreement, with subsequent annual payments required for continued licensing and service contracts.
The quality of input images is highly critical, as the software's AI features depend heavily on it for optimal performance. Robust data integration and high-quality imaging are essential to ensure accurate results and effective utilization of the AI's capabilities in image fusion and subsequent planning.
No, the AI in Brainlab Elements Image Fusion 5.0 is designed to assist and enhance surgical and treatment planning, not to replace the physician's role. It processes image data to aid interventions, but the physician's expertise remains crucial for interpreting the data, making final diagnostic decisions, and formulating treatment plans.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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