Broncholab
Fluidda Inc.Broncholab is a software tool that helps doctors analyze CT scans of the lungs by providing detailed quantitative information about lung volume, airway volume, lung density, and other pulmonary tissue characteristics. It assists in the diagnosis and follow-up of lung abnormalities by creating 3D models and measurements from CT images, supporting clinical decision-making.
Intended Use
Broncholab provides physicians with reproducible CT values for pulmonary tissue for quantitative support in diagnosis and follow-up examination of pulmonary tissue images from CT thoracic datasets.
Technology
Broncholab is a SaMD that uses CT images compliant with DICOM 3.0 standard to generate 3D models of patient-specific lungs. It combines image processing techniques for 3D segmentation, volumetric analysis, density evaluation, low-density cluster analysis, fissure evaluation, and reporting, delivered via a web portal and report generation.
Performance
Verification and validation testing demonstrated equivalence to the primary predicate device (Vida Pulmonary Workstation 2) with less than 5% difference in key lung structure parameters including lobe volume, emphysema, blood vessel density, and fissure integrity. Testing used datasets from a variety of CT scanners and included manual segmentations by physicians as ground truth.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/12/2019
8 months - 2
FDA Approval
3/4/2020
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