Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
Brainlab AGBrainlab Elements is a suite of software applications that process and analyze medical image data from various modalities to assist clinicians in planning surgeries and radiation treatments. It offers tools for image registration (fusion), segmentation (contouring), diffusion tensor imaging (fibertracking), blood oxygen level dependent MRI analysis (BOLD MRI mapping), and cerebrovascular image fusion (Image Fusion Angio). These capabilities help improve precision and understanding of patient anatomy and function during clinical procedures.
Intended Use
Brainlab Elements are software applications indicated for the processing of medical image data to support image guided surgery and radiation treatment planning.
Technology
Brainlab Elements transfers DICOM data and includes modules for 2D/3D image viewing, processing, co-registration (rigid and deformable registration), segmentation, and 3D visualization. It incorporates AI via a convolutional neural network for tumor segmentation on T1-weighted contrast-enhanced MR images, and supports various modalities such as CT, MRI, PET, SPECT, ultrasound, and angiography.
Performance
Performance testing included software verification with integration and unit tests, impact analysis for changes, interoperability tests for new components, and pre-clinical clinical validation demonstrating safety, performance, suitability, and benefits for treatment planning in cranial and ENT surgeries and radiotherapy.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2022
9 months - 2
FDA Approval
7/14/2023
Other devices from Brainlab AG
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