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510(k) Data Aggregation

    K Number
    K241312
    Device Name
    TeraRecon Cardiac.Chambers.MR (1.0.0)
    Manufacturer
    Date Cleared
    2024-11-05

    (180 days)

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

    TeraRecon,Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This medical device is intended to segment Cardiac chambers as anatomical structures on contrast or non-contrast MR scans of adult patients that undergo Cardiac MR procedures. The algorithm is not specific to any gender or ethnic group or clinical conditions.
    Device Description
    The TeraRecon Cardiac.Chambers.MR algorithm is comprised of two components: 1. The TeraRecon Cardiac.Chambers.MR for Cine-ax 2. The TeraRecon Cardiac.Chambers.MR De-ax 1: The TeraRecon Cardiac.Chambers.MR for Cine-ax The TeraReconCardiac.Chambers.MR algorithm for Cine-ax is an image processing software device that can be deployed as a containerized application (e.g.,Docker container). The TeraRecon Cardiac.Chambers.MR algorithm for Cine-ax automatically detects and identifies the heart location and derives left ventricular (LV) and right ventricular (RV) myocardium segmentation on DICOM-compliant cardiovascular MR images of different cardiac imaging sequences. The TeraRecon Cardiac.Chambers.MR for Cine-ax algorithm performs a segmentation (or tracing) around the epicardial border as well as the endocardial border wall. For the RV the algorithm segments the endocardial border wall. 2: The TeraRecon Cardiac.Chambers.MR for De-ax The TeraReconCardiac.Chambers.MR algorithm for De-ax is an image processing software device that can be deployed as a containerized application (e.g.,Docker container). The TeraRecon Cardiac.Chambers.MR algorithm for De-ax automatically detects and identifies the heart location and derives left ventricular (LV) myocardium segmentation on DICOM-compliant cardiovascular MR images of different cardiac imaging sequences. The TeraRecon Cardiac.Chambers.MR for De-ax algorithm performs a segmentation (or tracing) around the epicardial border as well as the endocardial border wall.
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