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510(k) Data Aggregation

    K Number
    K083227
    Device Name
    VIDA PULMONARY WORKSTATION 2 (PW2)
    Manufacturer
    VIDA DIAGNOSTICS, INC.
    Date Cleared
    2008-11-18

    (15 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 Pulmonary Workstation 2 (PW2) software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The PW2 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 Pulmonary Workstation 2 (PW2) 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 Pulmonary Workstation 2 (PW2) is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format. VIDA Pulmonary Workstation 2 (PW2) can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D seamentation & isolation of sub-compartments. volumetric analysis, density evaluations, and low density cluster analysis) and reporting tools are combined with a dedicated workflow. The PW2 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 threedimensional space ("voxel"). The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry. Figure 1 shows the basic Input/ Output of the CT volume converting to a digitized, colorized picture. PW2 provides computed tomography (CT) viewing, airway analysis, and parenchymal density analysis in one application. PW2 provides imaging of bronchial airways that can be used to assess therapy effectiveness based on CT scan data. PW2 reconstructs multiple cross-section images from CT data into a computer model displaying complex bronchial branches. PW2 does not interface directly with any CT or data collection equipment; instead PW2 imports data files previously generated by such equipment. PW2 provides quantitative measurements and tabulates quantitative properties. PW2 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 errorprone manual tasks. The software has functions for loading, analyzing, saving datasets and will generate screen displays, computations and aggregate statistics.
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