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510(k) Data Aggregation

    K Number
    K232392
    Device Name
    CT Lung Ventilation Analysis Software (CT:V)
    Manufacturer
    Date Cleared
    2023-11-16

    (99 days)

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

    4DMedical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CT:V software is a non-invasive image processing technology that measures volume changes from paired inspiration-expiration CTs to quantify and visualize regional and global ventilation. These regional measures are derived entirely from the lung tissue displacement and lung volume change between the paired inspiration-expiration chest CTs. CT:V is for use in adult patients. Quantification and visualizations are provided in the form of a report. CT:V may be used when physicians need a better understanding of a patient's lung function and/or respiratory condition.
    Device Description
    CT:V Software (i.e. the "Device"), also known as "CT:V", is a software-based image processing technology that analyzes two non-contrast Computed Tomography (CT) images of the lungs to quantify the reqional ventilation of pulmonary tissue to support clinicians in their assessment of patient lung conditions and diseases. CT:V is provided on a 'Software as a Service' basis. The paired CT series, in DICOM format, are transferred electronically to 4DMedical. The images are input into the Software Device that operates in a cloud environment. The Device is fully automated and assesses the CT series and identifies and segments the lungs. CT:V measures ventilation captured in the CTs by directly measuring the motion field of the lung tissue at thousands of points using a form of three-dimensional motion tracking. This motion tracking quantifies the expansion of lung tissue, and hence airflow (i.e. ventilation) is determined. These regional lung motion and ventilation measurements are used to provide quantitative outputs and color maps showing ventilation within a segmented region. An Analysis Report is generated for each completed workflow which is returned to the requesting physician. The ventilation data presented in the CT:V Report provides the user with additional information that may assist in characterizing the patient.
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