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510(k) Data Aggregation

    K Number
    K082526
    Device Name
    CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
    Date Cleared
    2009-01-05

    (125 days)

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

    MRI CARDIAC SERVICES, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cardio Vue Quantitative Analysis TM is an integrated software component of the CardioVue (K060840) medical image management device that analyzes DICOMcompliant cardiovascular images acquired from MRI scanners and produces reports. CardioVue Quantitative Analysis™ assists qualified cardiologist, radiologist or other licensed professional healthcare practitioners in making their diagnosis by performing functional and blood flow analysis and in reporting their patient study findings. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
    Device Description
    CVQ is an add-on module to the proprietary software included in the CardioVue™ workstation (K060840.) CVQ provides clinical quantitative data by analyzing multi-slice, multi-phase DICOM compatible cardiovascular MR images. Functional and blood flow analysis is performed using 2D, 3D and 4D data sets using standard algorithms and user input. MR images may be imported from various sources including images stored on a Cardio Vue" workstation, portable media, network storage devices, PACS, and other vendors systems and supports cardiovascular MR images from all of the major MRI scanner vendors. CVQ can be used for the immediate analysis of cardiovascular MR images at the time of the patient study (real-time) or after the study (post processing.)
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    K Number
    K060840
    Device Name
    SVIEW
    Date Cleared
    2006-04-07

    (10 days)

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

    MRI CARDIAC SERVICES, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SView 1.0 is a medical image management device intended for viewing, manipulating and analyzing DICOM-compliant medical images acquired from MRI scanners and other DICOM -compliant imaging devices. SView™ 1.0 can be used for real-time image viewing, manipulation and analysis that aid a cardiologist or radiologist in their diagnosis. In addition, it facilitates the physician's reporting and reviewing of patient studies.
    Device Description
    SView " 1.0 is a tool for 2D (two-dimensional) viewing and manipulation of DICOM compliant MR images and other DICOM-compliant images. The proposed device provides real-time image viewing, manipulation, analysis and reporting.
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