icobrain is a medical device intended to be used by healthcare professionals only. The intended purposes of each software are listed below:
- icobrain mris intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images.
icobrain mr consists of two distinct image processing pipelines: icobrain mr cross and icobrain mr long.
- icobrain mr cross is intended to provide volumes from images acquired at a single time point.
- icobrain mr long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol, and with same contrast at two different timepoints.
The results of icobrain mr cross cannot be compared with the results of icobrain mr long.
- icobrain ctis intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of computed tomography (CT) images. This software is intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on CT images.
- icobrain ctpis an image processing software package that runs on a standard “off-the-shelf” computer or a virtual platform, such as VMware, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices. icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to cerebral blood flow and cerebral blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan, are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
For complete information about indications, contraindications, suggested procedures, warnings, precautions, and optimal usage conditions, we recommend consulting the instructions for use supplied with the software or by your local Guerbet representative(s). These devices may not be available in certain geographic areas as they may not have regulatory approvals. Please make sure to obtain the regulatory status of the product registration before using it in your country.
icobrain mr (from version: 5.15.0) / Class IIa / Compliant with Medical Device Regulation EU 2017/745 as amended / SGS Belgium NV NB1639
icobrain ct (from version: 6.4.0) / Class IIa / Compliant with Medical Device Regulation EU 2017/745 as amended / SGS Belgium NV NB1639
icobrain ctp (from version: 1.7.1) / Class IIa / Compliant with Medical Device Regulation EU 2017/745 as amended / SGS Belgium NV NB1639
Manufacturer: icometrix / SRN Number: BE-MF-000006329
icometrix (Icometrix NV Kolonel Begaultlaan 1b/12, 3012 Leuven, Belgium)
P22001526