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510(k) Data Aggregation

    K Number
    K200990
    Device Name
    VIDAvision
    Manufacturer
    VIDA Diagnostics Inc.
    Date Cleared
    2020-08-07

    (114 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIDA Diagnostics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VIDA|vision software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. VIDA|vision can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low density cluster analysis and reporting tools are combined with a dedicated workflow. The VIDA vision software package is also intended to be a real-time interactive evaluation in space and time for CT volume data sets that provides the reconstruction of two dimensional images into a three-dimensional image format.
    Device Description
    VIDA|vision is a self-contained image analysis software package. This real-time interactive evaluation in space and time of CT volume datasets provides the reconstruction of two-dimensional images into a three-dimensional image format. VIDA|vision can be used to support the physician in the diagnosis, treatment planning, and documentation of chest diseases, including lung cancer, asthma, COPD, interstitial lung disease and other lung abnormalities e.g. when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation (3D segmentation & isolation of sub-compartments, volumetric analysis, density evaluations, and low density cluster analysis), editing, and reporting tools are combined with a dedicated workflow. VIDA|vision is designed to analyze pulmonary CT slice data and display analysis results. Each voxel of the scan is measured by Hounsfield units (HU), a measurement of x-ray attenuation that is applied to each volume element in three dimensional space ("voxel"). The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry. VIDA|vision provides computed tomography (CT) viewing, airway analysis, and parenchymal density analysis in one application. VIDA|vision provides imaging of bronchial airways that can be used to assess therapy effectiveness and treatment plan based on CT scan data. VIDA|vision reconstructs multiple cross-section images from CT data into a computer model displaying complex bronchial branches. VIDA|vision provides quantitative measurements and tabulates quantitative properties. VIDA|vision focuses on what is visible to the eye and applies volumetric methods that might otherwise be too tedious to use. The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the intent of the software is to save time and automate potential error prone manual tasks. VIDA|vision has functions for loading, analyzing, and saving datasets, and will generate screen displays, computations and aggregate statistics. VIDA|vision data output may be exported in pdf format or to a csv file.
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