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)
Brainlab AGBrainlab Elements (7.0) is a suite of medical imaging software applications that aid clinicians in planning cranial and extracranial surgical and radiotherapy treatments. It provides tools for image fusion (aligning different imaging datasets), angiographic image registration, contouring (outlining anatomical structures), fibertracking (visualizing brain white matter tracts from diffusion imaging), and functional MRI mapping. The device supports precise treatment planning by combining and analyzing various imaging data, helping clinicians visualize critical anatomical and functional areas without being used for diagnostic purposes.
Intended Use
Applications for co-registration of imaging data, visualization and manipulation of anatomical structures, fiber tracking, and BOLD MRI data analysis for planning cranial and extracranial surgical and radiotherapy treatments. Not intended for diagnostic purposes.
Technology
The software suite includes multiple applications using rigid and deformable image registration, atlas-based automatic segmentation, fibertracking based on Diffusion Weighted Imaging with deterministic and probabilistic algorithms, BOLD MRI activation analysis, and visualization tools such as blending and spy glass for verification. Runs on Windows platforms with specific hardware requirements.
Performance
Performance testing involved software verification, usability evaluations, accuracy tests including validation of virtual iMRI for brain shift compensation, fibertracking algorithms, and AI-based tumor segmentation on 412 patients' MR images. Validation showed high precision, recall, and Dice similarity coefficients meeting acceptance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2024
6 months - 2
FDA Approval
6/13/2025
Other devices from Brainlab AG
- 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 RT2025 • 510K
- TraumaCad Neo (1.1)2025 • 510K
- Mixed Reality Spine Navigation2025 • 510K
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