The Imbio CT Lung Density Analysis Software assists physicians by automatically processing CT scans of the lungs to quantify lung tissue density and identify abnormalities. It provides tools for 3D segmentation, volumetric analysis, and reporting, helping in diagnosis and monitoring of pulmonary conditions.
Intended Use
The Imbio CT Lung Density Analysis Software provides reproducible CT values for pulmonary tissue to support diagnosis and follow-up examinations, including analysis and documentation of pulmonary tissue abnormalities from CT thoracic datasets with 3D segmentation, volumetric analysis, and reporting tools.
Technology
A set of image post-processing algorithms performing segmentation, registration, thresholding, and classification on CT lung images. It operates as a command-line software that reads DICOM CT lung datasets, analyzes them, and outputs segmented lung images with color-coded results and reports. It imports DICOM files generated from CT scanners but does not interface directly with CT equipment.
Performance
Testing was conducted using CT datasets from COPDGene and DIR-Lab studies to verify segmentation, registration, thresholding, and classification functions, showing substantial equivalence to the predicate device. Software verification and validation were performed at unit, integration, and system levels. Quality assurance measures such as software lifecycle management, risk assessment, configuration management, and issue tracking were applied. Clinical testing was not required due to equivalence with predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/24/2014
4 months - 2
FDA Approval
9/17/2014
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