VBrain
Vysioneer Inc.VBrain is a software tool that helps medical professionals in planning radiation therapy for brain tumors. It uses artificial intelligence, specifically deep learning neural networks, to automatically outline brain tumors and organs at risk on MRI scans of the brain. This assists clinicians by providing initial contours that they can review and adjust, improving workflow efficiency and accuracy in treatment planning.
Intended Use
VBrain is a software device intended to assist trained medical professionals during radiation therapy treatment planning by providing initial contours of known brain tumors and organs at risk in axial T1 contrast-enhanced brain MRI images on adult patients.
Technology
The device uses deep learning neural networks within tumor and organ-at-risk contouring algorithm modules, plus a registration module for rigid image alignment of volumetric medical images (e.g., MR, CT). It operates as workflow management software integrated with PACS, producing DICOM-RT structured output for radiation therapy treatment planning.
Performance
Regression testing was performed to verify software changes and validate safety and effectiveness in accordance with FDA guidance for software in medical devices. The device passed all verification and validation tests, meeting performance requirements and specifications without introducing new risks.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/17/2021
29 days - 2
FDA Approval
12/16/2021
Other devices from Vysioneer Inc.
- VBrain-OAR2021 • 510K
- VBrain2021 • 510K
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