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510(k) Data Aggregation

    K Number
    K244012
    Device Name
    Mosaic (V1.0.1)
    Manufacturer
    Navier Medical
    Date Cleared
    2025-06-16

    (172 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Navier Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mosaic V1.0.1 is a medical image analysis system that allows the viewing, processing, and analysis of multi-dimensional digital images acquired with contrast from CT imaging devices. Mosaic V1.0.1 is intended to assist trained medical professionals in the stratification of patients suspected or identified to have atherosclerosis as well as stratification of patients suspected or identified to have aneurysmal disease of the aorta or carotid, iliac, femoral and popliteal arteries. The software enables post processing of images obtained using a multidetector CT and provides tools for the measurement and visualisation of arterial vessels and any disease present, including editing of contrasted lumen and artery boundaries. Any processed artery can be selected to view: the vessel in 3D; color-coded interactive data maps displayed on the 3D vessel; curved, straightened and cross-sectional MPR views of the vessel; and quantitative data from regions of interest. Data includes standard 2D distance measurements as well as stenosis, Hounsfield unit statistics, and tissue volumes. Typical users of Mosaic V1.0.1 outputs are trained medical professionals, including radiologists and clinicians. Typical operators of Mosaic V1.0.1 are those suitably trained in the use of the software. Mosaic V1.0.1 is intended to complement standard of care but is not intended to provide a diagnosis or clinical recommendation.
    Device Description
    Mosaic V1.0.1 is a post-processing tool used to analyse arterial diseases. It reads in computed tomography angiography (CTA) scans and users can process the scans to aid clinicians in their analysis of anatomy and pathology. Processing CTA with Mosaic enables the creation of vessel centrelines from which measurements and image reformatting is possible. The outputs of the software include visual images, measures of diameter, distance, volume, including plaque volumes, positive remodelling of the arterial wall, and stenosis. These measurements are based on user segmentation. Outputs from Mosaic, including the saved analysis file and PDF report, can be used to assist with the decision-making process and clinical management of the patient, but Mosaic is not intended to be used as a sole source of clinical data to determine diagnosis and/or treatment pathways.
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