Myrian® software, a class II medical device, is developed, manufactured and distributed by Intrasense SA. Myrian is a software for processing, management, advanced visualization and analysis of multimodality medical images.This medical device is not FDA cleared, it is intended for presentation or demonstration purposes only and cannot be made available until it has been brought into compliance with US Medical Device Regulation.
Myrian® 2.13 carries the CE 0459 mark in accordance with the requirements of;regulation 745/2017 on medical devices.
As Myrian® is a medical device, non-refundable, it is intended for use by healthcare professionals only. Precautions for use must be implemented, consult instructions for use for more information.
Myrian® XP-Prostate option AI available with Myrian® 2.13 is an AI option of the variant Myrian® XP-Prostate.
Myrian® XP-LungNodule option AI available with Myrian® 2.13 is an AI option of the variant Myrian® XP-LungNodule.
Intrasense® and Myrian® are either registered trademarks or trademarks of Intrasense SA in France and/or other countries.
Intrasense - 1231 Avenue du Mondial 98 - 34 000 Montpellier (France).
Liflow® software, a class II medical device, is developed, manufactured and distributed by Intrasense SA. Liflow is an application dedicated to the interpretation of oncology examinations. This medical device is not FDA cleared, it is intended for presentation or demonstration purposes only and cannot be made available until it has been brought into compliance with US Medical Device Regulation.
Liflow® 1.0 carries the CE 0459 mark in accordance with the requirements of regulation 745/2017 on medical devices.
As Liflow® is a medical device, non-refundable, it is intended for use by healthcare professionals only. Precautions for use must be implemented, consult instructions for use for more information.
A new version of Liflow® 2.0 is under CE 0459 evaluation.
Intrasense® and Liflow® are either registered trademarks or trademarks of Intrasense SA in France and/or other countries.
Intrasense - 1231 Avenue du Mondial 98 - 34 000 Montpellier (France).
DUOnco™ Liver, a class II medical device, is developed, manufactured and distributed by Intrasense SA. DUOnco™ Liver is a software intended to assist the analysis and review of contrast-enhanced (portal phase) CT scan images containing the liver through the automatic detection and measurement of liver lesions. This medical device is not FDA cleared, it is intended for presentation or demonstration purposes only and cannot be made available until it has been brought into compliance with US Medical Device Regulation.
DUOnco™ Liver carries the CE 0459 mark in accordance with the requirements of regulation 745/2017 on medical devices.
As DUOnco™ Liver is a medical device, non-refundable, it is intended for use by healthcare professionals only. Precautions for use must be implemented, consult instructions for use for more information.
Intrasense® and DUOnco™ are either registered trademarks or trademarks of Intrasense SA or Guerbet in France and/or other countries.
Intrasense - 1231 Avenue du Mondial 98 - 34 000 Montpellier (France).
The algorithms DUOnco™ Bone and DUOnco™ Pancreas are products under development, for presentation or demonstration purposes only.
GU09240159 - December 2024
GU09240166 – December 2024
icobrain is a medical device intended to be used by healthcare professionals only. The intended purposes of each software are listed below:
icobrain mr is 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.
The results of icobrain mr cross cannot be compared with the results of icobrain mr long.
icobrain ct is 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 ctp is 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)