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510(k) Data Aggregation

    K Number
    K242166
    Device Name
    TribusConnect
    Date Cleared
    2025-03-31

    (250 days)

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

    TribusMed Beheer BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TribusConnect is a medical image management and processing device which facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources. TribusConnect is suitable for, but not limited to, pre-procedural planning of cardiac interventions and post procedural analysis of cardiac interventions. To facilitate the above, TribusConnect uses CT DICOM data to output volume renderings, ML-based heart segmentation, a simulated fluoroscopy view, endo views, MIP and MPR views. Measurements can only be performed on MPR views. TribusConnect is not intended for diagnostic use on mobile displays. TribusConnect is not intended to serve as the primary archive for medical imaging data. TribusConnect is an adjunct tool and is not intended to replace a physician's own review on the images. The intended patient population is comprised of adult patients (22 years of age and older)
    Device Description
    TribusConnect is a cloud-based software application that facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources through a secure internet connection. TribusConnect offers a secure and efficient solution for accessing, reviewing, and visualizing CT images in DICOM format. Measurements can be performed on MPR views. TribusConnect is provided to its users as a Saas solution, TribusMed will be in control of installation, configuration, updates etc. TribusConnect can be used in healthcare facilities, hospitals, and remote locations, including home environments, when accessed by authorized users through a secure internet connection. CT scans can be uploaded to the server and will be de-identified before the upload. On the server the heart structures will be segmented using a ML based algorithm. Also a ML based semi-automated localization of the Left Atrial Appendage (LAA) will be performed. All rendering of image data is done on the server te results can be viewed on standard computing devices (e.g., desktop, laptop, tablet, smartphone) with an internet connection. Images can be rendered as Volume rendering, segmentations, simulated fluoroscopy, endo view, MIP or MPR. The user can interact with the data like zooming, rotating, changing the window. On the MPR views measurements can be performed. The device's cloud infrastructure and encryption protocols ensure data protection and compliance with security standards.
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