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510(k) Data Aggregation
K Number
K241989Device Name
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
Manufacturer
Date Cleared
2024-12-06
(151 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Cercare Medical A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cercare Medical Neurosuite (CMN) and associated modules is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The CMN 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 imaging devices. CMN provides viewing capabilities of datasets acquired with CT and MRI.
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 and CT). 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.
The Virtual Expert module allows the calculation of regions of interest and the visual inspection of time attenuation curves. For MRI, one clinical application is to visualize the apparent blood perfusion and diffusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
For CT, one clinical application is to visualize the apparent blood perfusion and to calculate rCBF threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
Areas of decreased perfusion appear as areas of changed signal intensity:
- Lower signal intensity for CBF and CBV
- Higher signal intensity for TTP, MTT, and Tmax
Device Description
Cercare Medical Neurosuite is a software-only device designed to streamline medical inage 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. CMN works with MRI (Magnetic Resonance Image) and CT (computed tomography) technologies.
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.
CMN 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 or perfusion CT 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 and CT technologies.
CMN Virtual Expert:
Virtual Expert, when activated in the installed CMN Capillary Function, provides further functionalities for reading, writing, visualizing, and studying medical images.
Virtual Expert provides automatic delineation of regions of interest (ROI) relevant for stroke patient assessment based on perfusion and diffusion image output generated by the Capillary Function module. Specifically, diffusion MRI images are used to generate threshold masks of perceived core lesions, whereas MRI or CT perfusion images are used to generate threshold masks of perceived perfusion restriction. For CT perfusion, derived perfusion images are used to generate threshold masks of perceived core lesions. Virtual Expert thus works with MRI and CT technologies.
The generated masks can be combined into a mismatch region of interest.
Volumetric calculations and ratios can be calculated from the computed regions of interest.
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K Number
K230016Device Name
Cercare Medical Neurosuite
Manufacturer
Date Cleared
2023-07-14
(192 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Cercare Medical A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cercare Medical Neurosute and associated 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 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.
The Virtual Expert module allows the calculation of regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
Areas of decreased perfusion appear as areas of changed signal intensity:
- · Lower signal intensity for CBF and CBV
- · Higher signal intensity for TTP, MTT, and Tmax
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. CMN works 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.
Virtual Expert, when activated in the installed CMN Capillary Function, provides further functionalities for reading, writing, visualizing, and studying medical images.
Virtual Expert provides automatic delineation of regions of interest (ROI) relevant for stroke patient assessment based on perfusion and diffusion image output generated by the Capillary Function module. Specifically, diffusion MRI images are used to generate threshold masks of perceived core lesions, whereas perfusion MRI images are used to generate threshold masks of perceived perfusion restriction. Virtual Expert thus works with MRI technology.
The generated masks can be combined into a mismatch region of interest.
Volumetric calculations and ratios can be calculated from the computed regions of interest.
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Ask a specific question about this device
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