Intended Use

Software medical device for automatic annotation, visualization, and quantification of segmentable brain structures from brain MRI scans, with cross-sectional and longitudinal analysis pipelines.

Technology

Uses pre-trained convolutional neural networks (CNNs) for brain structure segmentation, preprocessing components to standardize MRI input, and post-processing for report generation. Operates as standalone software integrated with clinical PACS systems to output volumetric reports and DICOM images with annotations.

Performance

Tested on in-house and public MRI datasets totaling thousands of scans from multiple vendors. Validation used manual expert annotations with high accuracy metrics (e.g., DICE scores >0.7 for segmentation). Bench testing verified performance across multiple modules with all tests passing acceptance criteria.

Predicate Devices

No predicate devices specified

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