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510(k) Data Aggregation

    K Number
    K211611
    Device Name
    QIR Suite
    Date Cleared
    2022-09-30

    (493 days)

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

    **CASIS Cardiac Simulation **& Imaging Software

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    QIR Suite is intended to be used for viewing, post-processing, and quantitative evaluation of cardiovascular Magnetic Resonance (MR) images in a DICOM (Digital Imaging and Communication in Medicine) Standard format. The software has been validated for use on adult patients. QIR Suite comprises QIR-MR for analysis of MR images. QIR-MR is composed of a viewer and analysis modules, and uses user inputs, standard algorithms, and/or automated deep learning detection algorithms. QIR Suite support the following functionalities: · Receive, store, transmit, post-process, display, and manipulate medical MR/CT images in the DICOM format (all transfer syntaxes supported including JPEG2000). - · Client/server functionalities to connect to a PACS (Picture Archiving and Communication System), to a HL7 server. · Visualization of 2D and 2D + time of single or multiple MR datasets. - · Segmentation of regions of interest. - · Measurement of distances and areas. · Cardiac function MR analyses for the four chambers, including ejection assessment, local myocardial mass, diastolic function, thickness and thickening. • 2D Flow studies. Each module generates an automated report of the analysis. QIR Suite allows connection and storage of analyses on a PACS and on a HL7 server. The software is not intended for use by patients, but rather by qualified medical professionals, experienced in examining and interpreting cardiovascular MR images to obtain diagnostic information as part of a comprehensive diagnostic decision-making process. OIR Suite cannot replace the diagnosis of a qualified practitioner and cannot be regarded as a sole medical point-of-view. The final diagnosis is the sole responsibility of the practitioner.
    Device Description
    QIR Suite is a software for quantitative analyses of cardiovascular magnetic resonance images in the DICOM format. Analyses are performed using standardized and deep-learning algorithms. QIR Suite has been validated for adult patients. QIR Suite is intended to be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images for the purpose of obtaining diagnostic information, as part of a comprehensive diagnostic decision-making process. QIR Suite cannot replace the diagnosis of a qualified practitioner and cannot be regarded as a sole medical point-of-view.
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