Brainomix 360 e-Lung
Brainomix LimitedBrainomix 360 e-Lung is a software tool designed to assist physicians by providing automated, quantitative analysis of chest CT images. It offers 3D segmentation, volumetric measurements, and density evaluations of lung tissue to support diagnosis and longitudinal assessment of lung diseases, enhancing workflow efficiency and accuracy in radiological interpretation of CT thoracic scans.
Intended Use
The e-Lung software provides reproducible CT values for pulmonary tissue, essential for quantitative support in the examination of radiological findings. It is a workflow enhancement and visualization tool for assessing CT thoracic datasets supporting physicians examining pulmonary and thoracic tissue.
Technology
Brainomix 360 e-Lung is a stand-alone DICOM-compliant software package running on off-the-shelf servers. It uses AI/ML image processing algorithms to automatically segment lungs from chest CT images and provides volumetric and density measurements, editing, reporting tools, and visualization via Web UI, PACS, and cloud. It automates image loading, processing, and report generation within a dedicated workflow.
Performance
The lung segmentation algorithm was validated through a head-to-head clinical comparison with a predicate device, showing significantly higher Dice Similarity Coefficient values against ground truth masks created by three experienced radiologists. The device performed well across diverse patient demographics, scanner types, and image acquisition parameters. Software verification and validation tested features including longitudinal assessment and outputs to PACS and cloud, demonstrating conformance to design requirements and specifications.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/14/2024
6 months - 2
FDA Approval
2/19/2025
Other devices from Brainomix Limited
- Brainomix 360 e-ASPECTS2025 • 510K
- Brainomix 360 e-CTA2025 • 510K
- Brainomix 360 Triage Stroke2023 • 510K
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