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510(k) Data Aggregation

    K Number
    K202793
    Device Name
    Cercare Medical Neurosuite
    Date Cleared
    2021-05-17

    (237 days)

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

    Cercare Medical ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cercare Medical Neurosuited modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians. The software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant MR imaging devices. Cercare Medical Neurosuite provides viewing capabilities, whereas the Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI). The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
    Device Description
    Cercare Medical Neurosuite is a software-only device designed to streamline medical image processing by providing for the visualization and study of medical images. CMN can be installed on a customer PC or it can be accessed remotely using remote desktop technologies. CMN provides viewing, quantification, analysis and reporting capabilities. CMN is not intended as a dedicated PACS system for long term persistent storage of patient data. CMN is software that is intended for use by trained professionals, including physicians and medical technicians. The software provides cerebral image processing capabilities. CMN is intended to be used as decision support software only and the clinician continues to provide all treatment decisions. The software is intended to visualize and study neuroimaging by image viewing and registration of medical images obtained with MRI (Magnetic Resonance Image) technology. CMN accepts and produces data sets in the DICOM format. DICOM is a standard format for storing and transmitting medical image data in vendor neutral format and is managed by the DICOM Standards Committee. CMN is a platform that allows for the addition of certain modules for further analysis. One of these modules included in this submission is Capillary Function. Capillary Function, when activated in the installed Cercare Medical Neurosuite, provides further functionalities for reading, writing, visualizing and studying medical images. Capillary Function provides perfusion post-processing technologies, where dynamically acquired perfusion MRI series can be processed to yield information relevant for assessment of the hemodynamic status of a patient. Capillary Function generates hemodynamic markers, which can be used for management of diseases with possibly compromised hemodynamic function, such as ischemic stroke and tumors. The generated output maps can be viewed by standard DICOM image viewers. In addition, Capillary Function includes the possibility for post-processing diffusion-weighted imaging (DWI) MRI data. Post-processing of DWI data results in maps reflective of local water diffusion properties. The post-processed DWI-derived maps can be viewed in standard DICOM image viewers. Capillary Function thus works with MRI technology.
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