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510(k) Data Aggregation

    K Number
    K173821
    Device Name
    LungQ Software
    Manufacturer
    Thirona Corporation
    Date Cleared
    2018-06-05

    (169 days)

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

    Thirona Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thirona LungQ software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The Lung Q software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluation, fissure evaluation, and reporting tools are provided.
    Device Description
    The LungQ software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. LungQ is standalone command-line software which must be run from a command-line interpreter and does not have a graphical user interface.
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