Brainlab Elements Image Fusion Angio (1.0)

by Brainlab AG  · Based in Germany →Innovating medical technology for precise surgical and radiotherapy planning.
Neurosurgery Oncology Radiology

Contact vendor for pricing
Regulatory Status Disclosed

Overview

Brainlab Elements Image Fusion Angio (1.0) is a specialized software application designed for the co-registration of cerebrovascular medical image data. Developed by Brainlab AG, the software processes and aligns complex vascular datasets to support clinicians during pre-planning phases.

The application is primarily utilized by neurosurgons, neuroradiologists, and radiation oncologists in hospital and specialized surgical or radiotherapy centers. It is indicated for the planning of cranial surgical treatments and the preplanning of cranial radiotherapy treatments.

In a clinical workflow, the tool integrates into the pre-planning stage by allowing clinicians to combine planar digital subtraction angiography (DSA) images with volumetric imaging datasets, such as CT or MRI. This co-registration helps align anatomical and vascular structures, streamlining the target definition process for cranial interventions.

Notable Capabilities:

  • Vascular Co-Registration: Specifically designed to align 2D and 3D cerebrovascular datasets, including angiography, to assist in mapping complex vascular structures.
  • Workflow Integration: Works alongside other modules in the Brainlab Elements suite, such as Contouring and Fibertracking, to build a comprehensive anatomical model.
  • Flexible Deployment: Supports DICOM data transfer and can be accessed across multiple platforms, including dedicated planning workstations and mobile devices.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Co-registration of cerebrovascular image data
  • Image fusion (aligning different imaging datasets)
  • Angiographic image registration
  • Supports planning of cranial surgical treatments
  • Supports preplanning of cranial radiotherapy treatments
  • Visualization of anatomical structures
  • Integration with other Brainlab Elements modules (e.g., SmartBrush Angio, Mixed Reality Viewer)
  • Utilizes 2D DSA and 3D rotational angiography-based Cone-Beam CT Angiogram (CBCTA)
  • Frameless co-registration
  • Not intended for diagnostic purposes

Use Cases

  • Planning cranial surgical treatments
  • Preplanning cranial radiotherapy treatments
  • Stereotactic radiosurgery (SRS) for intracranial arteriovenous malformations (AVMs) and dural arteriovenous fistulas (DAVFs)
  • Enhanced surgical planning review with patient-specific 3D data
  • Combining insights from planar digital subtraction angiogram (DSA) with volumetric imaging data

What Physicians Need to Know

Brain MRI/CT Analysis
Brainlab Elements Image Fusion Angio (1.0) is designed for the co-registration of cerebrovascular image data, including 2D digital subtraction angiography (DSA) to 3D vascular images (MRA, CTA, 3D DSA). It supports the fusion of CT, MRI, and angiographic images, providing fast, automatic, and accurate co-registration between modalities for enhanced anatomical insights.
Triage Prioritization Speed
The software streamlines pre-planning workflows by enabling the use of pre-existing diagnostic angiography data, which can eliminate the need for repeat invasive procedures. This capability contributes to faster patient processing and aims to improve overall planning accuracy and efficiency.
Mobile Notification System
The broader Brainlab Elements suite supports clinicians on mobile devices (iPad and iPhone) for planning and review, suggesting a capability for accessing and reviewing data remotely.
Physician Tip

Brainlab Elements Image Fusion Angio (1.0) is intended for treatment planning, not for diagnostic purposes. It is highly effective for visualizing critical anatomical and functional areas by fusing various imaging data, including combining 2D digital subtraction angiography (DSA) with 3D vascular images to integrate flow and location information. The tool facilitates frameless radiosurgery by eliminating the need for invasive head-ring fixation and repeat angiography on the day of treatment, benefiting both patients and caregivers. Physicians can leverage its advanced segmentation tools and white matter tractography for patient-specific planning and utilize hyperrealistic three-dimensional visualization to anticipate the size and positioning of vascular clips before surgery.

Brainlab Elements Image Fusion Angio (1.0) is an integral part of the Brainlab Elements suite, designed for seamless integration into clinical workflows for image-guided surgery and radiation treatment planning. It integrates with Picture Archiving and Communication Systems (PACS) for efficient patient data access and supports various imaging modalities such as CT, MRI, PET, SPECT, and US for comprehensive co-registration. The suite also offers integration with advanced hardware like the Magic Leap 2 headset for immersive 3D visualization. Future developments are expected to enhance its capabilities through further integration of AI and machine learning technologies, aiming for more automated features and improved planning accuracy.

Details

Category Neurology AI, Oncology AI, Surgical AI
Pricing Contact vendor for pricing
DeploymentOn-premise (Windows), with cloud integration options
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

Brainlab Elements Image Fusion Angio (1.0) is part of the Brainlab Elements (7.0) suite, which received FDA clearance under K243633. It is indicated for the co-registration of cerebrovascular image data to aid in planning cranial surgical treatments and preplanning cranial radiotherapy treatments, and is not for diagnostic use.

Integrations
EHR Not specified
Specialties Neurosurgery, Oncology, Radiology

What the Web Says

Brainlab Elements Image Fusion Angio (1.0) is generally well-regarded for its ability to fuse different imaging modalities, particularly CT/MRI with angiography, to provide a more comprehensive view during neurosurgical and interventional procedures. Users appreciate its potential to enhance planning and navigation, though some note a learning curve and occasional workflow integration challenges.

Overall: Positive

Strengths

  • Improved visualization and understanding of complex anatomy by fusing multiple imaging types.
  • Enhances surgical planning and intraoperative navigation accuracy.
  • Potentially reduces radiation exposure by optimizing imaging use.
  • Streamlines workflow by integrating different image datasets.
  • Supports a wide range of neurosurgical and interventional applications.
  • User-friendly interface once proficiency is gained.

Limitations

  • Steep learning curve for new users.
  • Can be challenging to integrate seamlessly into existing hospital IT infrastructure.
  • Occasional software glitches or performance issues reported.
  • Cost of implementation and ongoing maintenance can be significant.
  • Requires high-quality input images for optimal fusion results.
  • Limited specific reviews for version 1.0, most discussions are on the broader Elements platform.

Based on reviews from: Brainlab.com, Medical device forums, Neurosurgical journals (mentions of Brainlab Elements), Healthcare IT reviews (general Brainlab platform), Physician discussions (anecdotal evidence)

Last updated: 2026-07-19

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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 is a software suite for processing and analyzing medical image data to aid in surgical and radiation treatment planning, including tools for image registration, segmentation, fibertracking, BOLD MRI analysis, and cerebrovascular image fusion (Image Fusion Angio). The Image Fusion Angio (1.0) specifically allows for co-registration of cerebrovascular image data to combine flow and location information.
2023-07
accessdata.fda.gov
FDA K243633 - 510(k) Premarket Notification
This FDA 510(k) premarket notification details the substantial equivalence determination for Brainlab Elements (7.0), which includes Brainlab Elements Image Fusion Angio (1.0), for processing medical image data to support image-guided surgery and radiation treatment planning. The decision date for this clearance was June 13, 2025.
2025-06
Innolitics
QIH u00b7 Automated Radiological Image Processing Software u2014 FDA Product Code | Innolitics
Innolitics lists Brainlab Elements Image Fusion Angio (1.0) as a recently cleared device under the FDA product code QIH for Automated Radiological Image Processing Software, with a clearance date of June 13, 2025. This product code encompasses software that provides automated radiological image processing and analysis tools, often incorporating AI via nonadaptive machine learning algorithms.
2025-06
510k Monitor
Brainlab AG u2014 FDA 510(k) clearances & recalls u00b7 510k Monitor
This page from 510k Monitor provides an overview of Brainlab AG's FDA 510(k) clearances, including Brainlab Elements Image Fusion Angio (1.0). It serves as a resource for tracking regulatory approvals for medical devices.
unknown
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 substantial equivalence of Brainlab Elements Image Fusion Angio (1.0) for planning cranial surgical and radiotherapy treatments. It highlights the software's capability to co-register 2D digital subtraction angiography images with 3D vascular images.
2025-06
Brainlab
CE marking - Brainlab
Brainlab's CE marking page indicates that Brainlab Elements Image Fusion Angio 1.0 has received CE 0123 certification from Tu00dcV Su00dcD Product Service GmbH, signifying its conformity with European health, safety, and environmental protection standards.
unknown
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 details the Brainlab Elements suite, including Image Fusion Angio (1.0), highlighting its capabilities in image fusion, angiographic image registration, and other tools for precise treatment planning. The FDA approval date for this suite was June 13, 2025.
2025-06

Videos

Product demos, reviews, and walkthroughs for Brainlab Elements Image Fusion Angio (1.0).

View all on YouTube

Frequently Asked Questions

Brainlab Elements Image Fusion Angio (1.0) incorporates AI features primarily for the identification of previously diagnosed lesions or tumors in T1-Weighted Contrast-Enhanced Magnetic Resonance (T1+C MR) volumetric images. This AI-powered identification assists in the co-registration of 2D digital subtraction angiography (DSA) with 3D vascular images, combining flow and location information for enhanced treatment planning.
Brainlab Elements Image Fusion Angio (1.0) is a Class II medical device that has received FDA 510(k) premarket notification clearance (e.g., K223106, K243633), indicating it is substantially equivalent to legally marketed predicate devices. This clearance confirms its compliance with safety and performance standards for processing medical image data to support image-guided surgery and radiation treatment planning.
A primary limitation is its dependency on proper hardware and user expertise for effective operation. The accuracy of the software's AI features heavily relies on the quality of the input images and the parameters set by the user. Additionally, it is not intended for diagnostic purposes, and its utility can be affected by the availability of specific imaging data, such as oblique angulation 2D-DSA pairs.
Brainlab Elements Image Fusion Angio (1.0) offers unique capabilities for frameless co-registration of 2D-DSA and 3D vascular images, aiming to reduce the need for invasive angiography on the day of treatment. While specific direct comparisons are complex, other vendors like Philips (Epiq CVxi with EchoNavigator) and Siemens (TrueFusion) also offer AI-enhanced fusion solutions for interventional procedures, often integrating different modalities like ultrasound and X-ray.
While direct pricing for this specific module is not publicly detailed, Brainlab Elements software is typically acquired through an outright purchase with a perpetual license. This usually includes a one-year licensing support agreement, with subsequent annual payments required for ongoing licensing support and service contracts.
As a medical device, Brainlab Elements Image Fusion Angio (1.0) is subject to stringent regulatory requirements for data handling, including compliance with regulations like 21 CFR Part 807 for registration and listing, and 21 CFR Part 820 for quality systems. While it stores patient information, it is often designed as a standalone system not directly interfaced with hospital computer systems like VA's, with updates handled on-site by the vendor, which helps manage data security.
Brainlab Elements applications are designed to transfer DICOM data to and from Picture Archiving and Communication Systems (PACS) and other storage media devices, facilitating integration into existing imaging workflows. The broader Brainlab Elements suite, including Image Fusion, is built to integrate into a surgeon's delivery platform of choice, supporting various stereotaxy use cases and offering customizable solutions for the operating room.

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