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510(k) Data Aggregation

    K Number
    K141069
    Device Name
    Lung Density Analysis
    Manufacturer
    IMBIO LLC
    Date Cleared
    2014-09-17

    (146 days)

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

    IMBIO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imbio CT Lung Density Analysis Software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The Imbio CT Lung Density Analysis Software can be used to support the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation of sub-compartments, volumetric analysis, density evaluations and reporting tools are provided.
    Device Description
    The Imbio CT Lung Density Analysis Software (Imbio LDA) is a set of image post-processing algorithms that perform image segmentation, registration, thresholding, and classification on CT images of human lungs. The algorithms within the Imbio CT Lung Density Analysis Software are combined into a single command-line executable program that may be run directly from the command-line or through scripting. The Imbio CT Lung Density Analysis Software program performs segmentation, then registration, then thresholding and classification. The program reads in DICOM datasets, processes the data, then writes output DICOM files to a specified directory. The Imbio CT Lung Density Analysis Software is a command-line software application that analyzes DICOM CT lung image datasets and generates reports and DICOM output that show the lungs segmented and overlaid with color-codings representing the results of its thresholding and classification rules. It has simple file management functions for input and output, and separate modules that implement the CT image-processing algorithms. Imbio CT Lung Density Analysis Software does not interface directly with any CT or data collection equipment; instead the software imports data files previously generated by such equipment.
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