(Elements) Dose Review

by Brainlab AG  · Based in Germany → — Digitizing medical workflows from diagnosis to therapy for better patient outcomes.
Oncology
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Regulatory Status Disclosed

Overview

Brainlab Elements Dose Review is a software application within the comprehensive Brainlab Elements suite, designed for advanced radiation therapy planning and review. The Elements suite provides immediate access to a range of pre-planning software applications that work seamlessly together, bridging various clinical subspecialties such as radiation oncology, neurosurgery, and spine surgery. Elements Dose Review specifically enables thorough analysis of dose distribution to target volumes and critical structures, offering features like zoom-adaptive dose display, dose-volume histograms for detailed plan review, and the ability to compare different plan alternatives. This helps clinicians illuminate options and gain reassurance prior to treatment delivery. The broader Elements platform also includes AI-powered segmentation for various anatomical regions, including cranial, basal ganglia, head & neck, pelvic, spine, and extracranial areas, as well as tools for image fusion and trajectory planning, all aimed at streamlining workflows and enhancing precision in treatment planning.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Thorough dose-to-target and dose-to-critical-structures models
  • Plan comparison and review
  • Zoom-adaptive dose display
  • Dose-volume histograms for detailed plan review
  • Comparison of plan alternatives
  • AI-powered tumor segmentation (within Elements Retreatment Review)
  • Image fusion and co-registration
  • Patient anatomy segmentation
  • Modular software applications
  • Multi-platform flexibility (workstation, mobile devices)

Use Cases

  • Radiation treatment planning
  • Stereotactic Radiosurgery (SRS) planning
  • Surgical planning (e.g., neurosurgery, spine surgery)
  • Retreatment analysis and planning for recurring lesions
  • Pre-planning for cranial and extracranial surgical and radiotherapy treatments
  • Functional neurosurgery planning (e.g., DBS, sEEG, biopsies)

What Physicians Need to Know

Key Capabilities
Offers thorough dose-to-target and dose-to-critical-structures models, plan comparison, zoom-adaptive dose display, and dose-volume histograms (DVHs) for detailed plan review. It includes features for reviewing isodose lines, dose comparison, and dose summation, particularly valuable for re-irradiation planning. For retreatment, it provides 3D visualization of previously treated and new metastases with automatic alignment of prior treatment information.
Clinical Utility
Provides reassurance before treatment and supports optimal decision-making for potential retreatment cases by offering a comprehensive overview of prior treatments and current patient status. It facilitates balancing efficacy and safety during repeat stereotactic radiosurgery near previously irradiated areas through cumulative-dose-aware planning. The tool aids in quality assurance by enabling recalculation of patient treatment plans on a phantom.
Integration Options
Part of the Brainlab Elements suite, it integrates with other modules like Multiple Brain Mets SRS, Cranial SRS, and Retreatment Review. It supports interoperability with Elekta linear accelerators (e.g., Versa HD with Agility MLC) for enhanced dose conformity and integrates with Brainlab ExacTracu00ae patient positioning and monitoring technology. The system allows import of prior treatment data from third-party systems and outputs DICOM RT dose plans. It offers multi-platform flexibility, accessible online via devices like iPad and iPhone, or offline on workstations.
Compliance Status
Brainlab Elements, including Dose Review, is classified as a Class II medical device and has received FDA clearance for various modules within the portfolio. It adheres to FDA regulations, including the Unique Device Identification System (UDI) Rule, and requirements for registration, labeling, medical device reporting, and good manufacturing practices.
Pricing Model
Brainlab offers flexible business models, ranging from single licenses to multiple departmental offerings. Specific pricing information is not publicly available, with indications that prices may vary by country, raw material costs, and exchange rates.
User Experience
Designed for a positive customer experience, it provides multi-platform flexibility for easy planning and review on various devices. The software features an intuitive 'traffic light' display for immediate plan analysis, indicating constraint fulfillment. It supports streamlined pre-planning workflows (Automate, Merge, Contour, View) and offers control via touch, mouse, and keyboard.
Support Quality
Brainlab provides scalable technical support to meet evolving departmental needs. Customer support is available during business hours, and comprehensive training options include documentation, webinars, live online sessions, and in-person training.
Implementation Complexity
The tool is designed for 'capability without complexity,' featuring easy setup and usage across devices. Implementation involves input of co-registered DICOM image sets with segmented objects. Software verification and validation are performed according to Brainlab's internal processes.
Evidence Base
Studies demonstrate that newer versions of Brainlab Elements generate SRS plans with comparable quality to manually optimized plans in less time. Research supports the accuracy of its Monte Carlo dose calculation algorithm, showing excellent agreement with measurements and superiority over pencil beam algorithms for small fields. Cross-platform verification studies confirm the feasibility of dose-summation-guided re-irradiation planning. Clinical feedback highlights impressive dosimetric results and efficient plan optimization.
Physician Tip

Leverage the dose summation and comparison features, especially for re-irradiation cases, to thoroughly assess cumulative dose to critical structures and previously treated areas. Utilize the intuitive plan analysis and DVHs to quickly evaluate plan quality and ensure all constraints are met. Explore the multi-platform access for flexible review and decision-making, even when away from the main workstation. Integrate with AI-powered segmentation (where available in related modules) for efficient delineation of new or recurring lesions to streamline the review process.

Brainlab Elements Dose Review is part of a comprehensive ecosystem. Its seamless integration with other Brainlab Elements modules (e.g., Multiple Brain Mets SRS, Retreatment Review) and platforms like Curveu2122 and Buzzu00ae optimizes workflow. Compatibility with Elekta linear accelerators and ExacTrac patient positioning systems enhances treatment delivery accuracy. The ability to import third-party data and export DICOM RT plans ensures interoperability within diverse clinical environments.

Details

Category Oncology AI
Pricing Contact for quote
  • Flexible business models ranging from simple, single licenses to multiple offerings across multiple departments
DeploymentOn-premise (workstation) and cloud-based services available
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

FDA 510(k) Premarket Notification K250440, cleared on 06/17/2025, includes (Elements) Dose Review, as well as other modules like (Elements) RT Planning Platform and (Elements) Segmentation for various anatomical regions (Cranial, Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial) and Elements AI Tumor Segmentation RT. The device is intended for radiation treatment planning for stereotactic, conformal, computer-planned, Linac-based radiation treatment and is indicated for cranial, head and neck, and extracranial lesions.
Integrations
EHR Not specified
Specialties Oncology

What the Web Says

Brainlab Elements Dose Review is a software module designed for comprehensive review and comparison of radiation treatment plans, focusing on dose-to-target and dose-to-critical-structures models. It is part of the broader Brainlab Elements suite, which offers various pre-planning solutions for radiotherapy and image-guided surgery. The software aims to enhance efficiency and accuracy in treatment planning for clinicians, providing thorough dose analysis and plan comparison capabilities.

Overall: Positive

Strengths

  • Thorough dose-to-target and dose-to-critical-structures models for comprehensive plan review.
  • Ability to compare plan alternatives.
  • Zoom-adaptive dose display and dose-volume histograms for detailed plan review.
  • Multi-platform flexibility, allowing use on various devices including iPad and iPhone.
  • Streamlines pre-planning workflow with intuitive modules and automation.
  • Enhances accuracy, safety, and confidence in the operating room.

Limitations

  • Dependency on proper hardware and user expertise for effective operation.
  • AI features are heavily dependent on input image quality and user-set parameters.
  • Earlier versions (e.g., Elements 2.0) sometimes required manual iterations and adjustments for optimal planning.
  • Potential for lagging, though this may be system-dependent.

Based on reviews from: Brainlab - PDF Catalogs | Technical Documentation, Brainlab - Wikipedia, Brainlab Elements Suite - Medical News Observer, Compare DoseLab vs. Elements Multiple Brain Mets SRS in 2026, Dosimetric Evaluation and Comparison of Brainlab Elements Version 2.0 and 3.0, Functional Neurosurgery Planning Solutions - Brainlab, Evaluation of Elements Spine SRS Plan Quality for SRS and SBRT Treatment of Spine Metastases - PMC, Rapid Commissioning of Brainlab Elements for SRS: End-to-End Evaluation of Monte Carlo and Pencil Beam Algorithms Across Homogeneous and Heterogeneous Phantom Environments - Frontiers, Evaluation of a Dedicated Software u201cElementsu2122 Spine SRS, Brainlabu00aeu201d for Target Volume Definition in the Treatment of Spinal Bone Metastases With Stereotactic Body Radiotherapy - Frontiers, K250440 - 510(k) Premarket Notification - FDA, Brainlab Elements: The Software Revolutionizing Modern Surgery - YouTube, Dose-Summationu2013Guided Re-irradiation Planning for Brain Metastases: Cross-Platform Verification Between Brainlab Elements and GammaPlan - PMC, June 17, 2025 Brainlab AG Sadwini Suresh QM Consultant Olof-Palme-Str. 9 Munich, 81829 Germany Re: K250440 Trade/Device Name: R - 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, Elements Software Pricing, Alternatives & More 2026 - Capterra

Last updated: 2026-07-18

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Press & Coverage

FDA
510(k) Premarket Notification - K142108
This FDA regulatory announcement details the 510(k) premarket notification for Brainlab AG's RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS, classified under regulation number 892.505023 with product code MUJ.
2026-05
FDA
510(k) Premarket Notification - K250440
This FDA premarket notification from June 2025 includes 'Elements Dose Review' as part of Brainlab AG's RT Elements software, which is a computer-based application for radiation therapy treatment planning and dose optimization.
2025-06
FDA.report
RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements ...
This entry lists 'Elements Dose Review' as part of Brainlab AG's RT Elements, a radiotherapy planning platform with product code MUJ, indicating its regulatory classification and use in radiology.
2025-06
X-ray Interpreter
Mixed Reality Spine Navigation | FDA Radiology AI Device
This article mentions 'Elements Dose Review' as one of the devices from Brainlab AG, alongside their Mixed Reality Spine Navigation, highlighting Brainlab's diverse portfolio of medical devices.
2025-05
Brainlab
CE marking - Brainlab
Brainlab's official CE marking document lists 'RT Elements u2013 Dose Review 3.0' with CE 0123 certification from Tu00dcV Su00dcD Product Service GmbH, indicating its compliance with European health, safety, and environmental protection standards.
unknown
MedicalExpo
Elements - Brainlab - PDF Catalogs | Technical Documentation
This technical documentation describes Brainlab Elements Dose Review as a tool for thorough dose-to-target and dose-to-critical-structures models, plan comparison, and review to offer reassurance prior to treatment.
2014-01
LA Vascular
rt elements 4 5 elements multiple brain mets srs elements cranial srs elements spine srs elements cranial srs w cones elements rt planning platform elements dose review elements retreatment review elements segmentation cranial basal ganglia head neck pelvic spine thoracic spine extracranial rt elements ai tumor segmentation rt elements smartbrush angio spine rt elements object management rt
This article highlights Brainlab AG's RT Elements platform, which includes 'Elements Dose Review,' as an FDA-cleared radiotherapy planning system for multiple brain and spine SRS applications, emphasizing its precision and AI-driven segmentation capabilities.
unknown
BEUDAMED
Brainlab Elements Guide XT, Guide 3.0 - BEUDAMED
BEUDAMED lists 'Elements Dose Review' as part of Brainlab Elements Guide XT, Guide 3.0, under regulation number 882.5855, indicating its role within Brainlab's medical device offerings.
2022-04

Videos

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