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510(k) Data Aggregation

    K Number
    K242500
    Device Name
    LARALAB
    Manufacturer
    LARALAB GmbH
    Date Cleared
    2025-04-16

    (237 days)

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

    LARALAB GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LARALAB enables visualization, assessment and measurement of cardiovascular structures for: - Preprocedural planning and sizing for cardiovascular interventions and surgery - Postprocedural image review To facilitate the above, LARALAB provides general functionality such as: - Automatic segmentation of cardiovascular structures and other objects of interest (calcifications) - Automatic measurements - Manual measurement and adjustment tools - Visualization and image reconstruction techniques: Multiplanar Reconstruction (MPR), Surface rendering - Reporting tools
    Device Description
    LARALAB is a stand-alone software developed to enable cardiologists, radiologists, heart surgeons and healthcare professionals ("Users") to import, view and process Medical Images. In particular, the software generates pre-calculated automatic segmentations and measurements based on deterministic Deep Learning Algorithms. Based on the output of the Deep Learning Algorithms, the User is able to further visualize, assess and measure ("Case Planning") various anatomical structures of the heart in the context of cardiovascular procedures (e.g., TAVR) such as heart valves, heart chambers, cardiac tissue and vessels, as well as such vessels and tissue relevant as access routes.
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