VIDAvision
VIDA Diagnostics Inc.VIDA|vision is an interactive imaging software that helps physicians analyze CT scans of the lungs. It uses deep learning algorithms to automatically segment lung regions and provides detailed quantitative analyses to assist in diagnosing and monitoring lung diseases such as lung cancer, COPD, and asthma. This software reconstructs two-dimensional CT images into 3D views and generates detailed reports, streamlining the workflow and reducing manual effort for clinicians.
Intended Use
The VIDA|vision software provides reproducible CT values for pulmonary tissue, essential for quantitative support in diagnosis and follow-up examinations. It supports diagnosis and documentation of pulmonary tissue images from CT thoracic datasets and provides 3D segmentation, volumetric analysis, density evaluations, and cluster analysis.
Technology
VIDA|vision is a standalone software that reconstructs 2D CT images into 3D image formats. It uses deep learning-based segmentation algorithms to automatically segment lung regions, measures voxels in Hounsfield units for detailed tissue differentiation, and provides volumetric, airway, and density analyses. It supports DICOM query/retrieve and generates exportable reports in PDF and CSV formats.
Performance
No human clinical testing was required for the device. Verification and validation testing included unit, regression, performance, and integrated system testing. Lung and lobe segmentation performance was tested against predicate devices to ensure substantial equivalence. The device met all product specifications and user needs within intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/15/2020
3 months - 2
FDA Approval
8/7/2020
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