VBrain-OAR

by Vysioneer  · Based in United States → — Revolutionizing cancer care through artificial intelligence and cloud service. Our mission is to make cancer care more accurate, more efficient and globally accessible.
Oncology Radiology

Not publicly available
Regulatory Status Disclosed

Overview

VBrain-OAR by Vysioneer is an FDA-clecleared AI-powered software application system designed to assist trained radiotherapy personnel in brain tumor radiation treatment planning. It specializes in the automated contouring (segmentation) of organs at risk (OAR) within the brain on MRI images, including the brain stem, eyes, optic nerves, and optic chiasm. The tool also features multi-modality image registration capabilities (e.g., MR, CT) to adjust the spatial position and orientation of images. Utilizing deep learning neural networks, VBrain-OAR generates initial object contours, which are then exported as DICOM-RT objects for review and finalization by medical professionals using external treatment planning systems. This aims to enhance the efficiency and precision of radiation therapy workflows for adult patients.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered auto-contouring (segmentation) of organs at risk (OAR) in the brain
  • Contouring of specific OARs: brain stem, eyes, optic nerves, optic chiasm
  • Multi-modality image registration (e.g., MR, CT)
  • Deep learning neural networks for contour generation
  • Workflow management module
  • DICOM-RT export of generated contours
  • Intended for use on adult patients only
  • Cloud-based platform

Use Cases

  • Assisting trained radiotherapy personnel during clinical workflows of brain tumor radiation therapy treatment planning
  • Providing initial object contours of organs at risk in the brain on axial T1 contrast-enhanced brain MRI images
  • Generating information for radiation treatment planning
  • Generating information for radiation treatment evaluation
  • Generating information for radiation treatment adaptation

What Physicians Need to Know

Brain MRI/CT Analysis
VBrain-OAR provides AI-powered auto-contouring of brain Organs-At-Risk (OARs) such as the brainstem, eyes, optic nerves, and optic chiasm on axial T1 contrast-enhanced MRI images. The VBrain product also performs auto-contouring for brain tumors including brain metastasis, meningioma, and acoustic neuroma. It includes an automatic image registration feature for multi-modality images (e.g., MR, CT) to adjust spatial position and orientation, specifically for radiation therapy treatment planning.
Triage Prioritization Speed
While not a diagnostic triage tool, VBrain significantly accelerates the radiotherapy treatment planning workflow. Automated contours are generated in less than a minute, reducing hours of manual contouring time to within a few minutes for clinician review and validation. This efficiency can decrease overall treatment planning time by a median of 30.8%.
Mobile Notification System
No specific mobile notification system for diagnostic alerts is mentioned. VBrain is described as a cloud-based software, implying accessibility, but not a dedicated notification system for the requested neurology use cases.
Physician Tip

VBrain-OAR is an assistive AI tool designed for trained radiotherapy personnel, including radiation oncologists, radiologists, neurosurgeons, radiation therapists, dosimetrists, and medical physicists. It significantly enhances the efficiency and consistency of brain OAR and tumor contouring for radiation therapy planning by providing initial, AI-generated contours. Clinicians should leverage VBrain-OAR to reduce manual contouring time and improve accuracy, especially for complex cases or less experienced personnel. However, it is crucial to remember that the AI-generated contours are meant for informational purposes and require thorough review and potential modification by a medical professional using an external treatment planning system to ensure patient safety and optimal treatment outcomes.

VBrain-OAR is a software device engineered for seamless integration into existing clinical workflows. It operates on a PACS network, allowing for the retrieval of patient scans. The system exports its auto-contoured results as DICOM-RT objects (RT Structure Set ROI Contour attribute, RTSTRUCT), which are compatible with external platforms such as image visualization software and treatment planning systems for final review and editing. Vysioneer has demonstrated integration with systems like CyberKnife and is described as a cloud-based solution, facilitating broader accessibility.

Details

Category Neurology AI, Oncology AI, Radiology & Imaging AI
Pricing Not publicly available
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

VBrain-OAR received FDA 510(k) clearance (K212116) on October 12, 2021. It is indicated for use in the contouring (segmentation) of brain MRI images for organs at risk (OAR) during radiation treatment planning and in the registration of multi-modality images.

Integrations
EHR Not specified
Specialties Oncology, Radiology

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Press & Coverage

X-ray Interpreter
VBrain-OAR | FDA Radiology AI Device - X-ray Interpreter
VBrain-OAR is an AI deep learning software device from Vysioneer Inc. designed to assist trained radiotherapy personnel in brain tumor radiation therapy treatment planning by automatically generating contours of organs at risk in brain MRI images. It also provides image registration functions to align multi-modality medical images and was approved by the FDA on October 12, 2021.
2021-10
accessdata.fda.gov
Vysioneer Inc. October 12, 2021 Vicki Lin Regulatory Specialist 33 Rogers St., # 308 CAMBRIDGE MA 02142 Re: K212116 Trade
This FDA 510(k) clearance document details VBrain-OAR's intended use for contouring organs at risk in the brain for radiation therapy planning, emphasizing that it does not alter original MRI images or detect tumors for diagnosis. The software showed clinically acceptable performance in testing and was deemed substantially equivalent to predicate devices.
2021-10
Innolitics
VBrain (K213628) u2014 FDA 510(k) | Innolitics
This regulatory filing from December 2021 discusses VBrain, a modified device that incorporates VBrain-OAR's organs at risk contouring algorithm, along with VBrain's tumor contouring algorithm and registration capabilities. It highlights that medical professionals must finalize the contours generated by the software using external platforms.
2021-12
Innolitics
Command Line as a Medical Device (CLaMD) - Innolitics
This article from May 2025 mentions VBrain-OAR in the context of 'Command Line as a Medical Device' (CLaMD), noting that users must finalize contours generated by the software using external DICOM-RT viewing/editing functions. It implies VBrain-OAR operates as a backend process without its own viewing interface.
2025-05
Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List - Orthogonal
VBrain-OAR by Vysioneer Inc. is listed among the Software as a Medical Devices (SaMD) cleared by the FDA, with its clearance date noted as October 12, 2021, and its specialty as Radiology. This comprehensive list compiles information from publicly available FDA reports.
2024-10
FDA.report
Vysioneer Inc. FDA Filings - FDA.report
This page provides a concise listing of Vysioneer Inc.'s FDA filings, including VBrain-OAR with a filing date of October 12, 2021.
2021-10
accessdata.fda.gov
TPLC - Total Product Life Cycle - accessdata.fda.gov
VBrain-OAR (K212116) is mentioned in this FDA Total Product Life Cycle document as substantially equivalent, alongside VBrain (K203235).
2026-06

Videos

Product demos, reviews, and walkthroughs for VBrain-OAR.

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Frequently Asked Questions

VBrain-OAR is an AI-powered software device designed to assist trained radiotherapy personnel in contouring organs at risk (OARs) in the brain on MRI images for radiation treatment planning. It provides initial object contours and automatic image registration, which can be integrated into your facility's external platform that supports DICOM-RT viewing and editing functions.
VBrain-OAR has received U.S. FDA clearance (K212116), indicating it has been reviewed for safety and effectiveness for its intended use. As a medical device, its use requires compliance with FDA regulations, including registration, listing, labeling, and medical device reporting.
VBrain-OAR is intended for adult patients only and specifically for contouring OARs in the brain; it is not for detecting tumors for diagnosis or use with other body parts. Importantly, the contours generated by VBrain-OAR are assistive and must be finalized (confirmed or modified) by trained radiotherapy personnel using an external platform.
VBrain-OAR aims to significantly improve efficiency and potentially accuracy by automating the initial contouring of OARs, a process that can take hours manually. While specific comparisons to all alternative AI solutions are not detailed, it is designed to provide a 'second set of eyes and hands' to clinicians, reducing treatment planning time and improving contouring accuracy.
Specific pricing details for VBrain-OAR are not publicly disclosed in the available information. However, similar healthcare AI software solutions typically operate on a subscription-based model, per-use fees, or an institutional licensing agreement, often with different tiers based on usage volume or features.
While specific training and support details are not explicitly mentioned, as an FDA-cleared medical device intended to assist trained professionals, comprehensive training and ongoing technical support would typically be provided by the vendor, Vysioneer Inc., to ensure safe and effective integration and use within clinical workflows.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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