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510(k) Data Aggregation

    K Number
    K982203
    Device Name
    CAAS II LVA BIPLANE OPTION
    Manufacturer
    PIE MEDICAL EQUIPMENT B.V.
    Date Cleared
    1998-07-14

    (22 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    PIE MEDICAL EQUIPMENT B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Delineate the outline of the left ventricular wall automatically and/or manually in angiographic X-ray images - either monoplane or biplane analysis; Absolute measurements of ventricular volumes - calculation of derived parameters; Quantification of the motion of the ventricular wall by applying several established models - Estimation of the dimensions of the myocardiac wall.
    Device Description
    The CAAS II LVA-Biplane Option is one of the software modules intended to run on the Cardiovascular Angiography Analysis System mark II, CAAS II. It functions in the same manner as other left ventricular analysis software packages. In the End Diastolic (ED) and End Systolic (ES) images (of a monoplane or biplane run), available from various image sources, the outline of the left ventricular contour is either drawn manually or detected automatically. From these contours the ventricular volumes, the ejection fraction and other related parameters are determined using either the Area Length or the Simpson's rule model. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall between ED and ES is quantified from these ventricular contours using four clinically and scientifically established models: the Centerline, Regional, Radial and Slager wall motion models. Finally myocardium dimensions can be estimated from the ED ventricular contour and a manually drawn outline of the epicardium. All results of the analysis are available on screen as well as hardcopy.
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