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510(k) Data Aggregation

    K Number
    K250766
    Device Name
    LungQ 4
    Manufacturer
    Thirona BV
    Date Cleared
    2025-10-02

    (203 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K232412
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Thirona LungQ software provides reproducible CT values for pulmonary tissue and specified endobronchial implants which is essential for providing quantitative support for diagnosis, treatment planning and follow up examination. The LungQ 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 evaluations, estimated chronic perfusion defect analysis, 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 a docker image with a standalone command-line software which must be run from a command-line interpreter and does not have a graphical user interface.

    AI/ML Overview

    N/A

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