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510(k) Data Aggregation

    K Number
    K101279
    Device Name
    CORRIDOR4DM V2010 MODEL: V2010
    Manufacturer
    INVIA
    Date Cleared
    2010-08-04

    (90 days)

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

    INVIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INVIA's Corridor4DM v2010 application is intended to provide processing quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the corònary arteries, a risk factor for coronary artery disease. Co-registration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
    Device Description
    Corridor4DM v2010 is a comprehensive application designed to process, review, and quantitatively analyze nuclear medicine, PET, and CT patient studies. The application provides tools to process, quantify, and display static, dynamic, gated planar,- standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. ECT data is displayed on both a slice-by-slice basis and as 3-dimensional surface- rendered images in many user selectable formats. All of the image formats can be viewed as a single dataset or as a comparison of related datasets. Among several optional display screens are sideby-side displays optimized for the review of uncorrected and attenuation corrected cardiac images. . Corridor4DM v2010 algorithmically determines and displays the left ventricular endocardial and epicardial surfaces. These surfaces provide quantitative assessments of cardiac functions. Corridor-4DM v2010 includes the ability to save and export diagnostic findings in a variety of formats. The application generates DICOM multi-frame (MFSC) and secondary screen captures (SSC) in addition to producing static (JPEG, TIFF) and dynamic (AVI) image files.
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    K Number
    K080575
    Device Name
    CORRIDOR4DM
    Manufacturer
    INVIA
    Date Cleared
    2008-05-13

    (74 days)

    Product Code
    KPS, AND, JAK
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack. Coregistration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
    Device Description
    Corridor4DM is a comprehensive cardiac emission computed tomographic (ECT) application designed to review and quantitatively analyze cardiac ECT (SPECT and PET) nuclear medicine patient studies. The application provides tools for processing and displaying standard ungated and ECG gated cardiac ECT images on both a slice-by-slice basis and as a 3-dimensional surface rendered images in many user selectable formats. Additionally, it provides quantitative assessments of heart function by computing and displaying left ventricular chamber volumes, ejection fraction and transient ischemic dilation (TID) values and provides an assessment of the data set(s) in comparison to a similar patient population with a low likelihood of cardiac disease. The application provides a number of different single or multi-dimensional display(s) to allow the users to select those that best fit their needs. Cardiac CT interpretation and cardiac calcium quantification are optional features that are integrated into Corridor4DM.
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