{"id":7066,"date":"2022-10-03T09:41:30","date_gmt":"2022-10-03T07:41:30","guid":{"rendered":"https:\/\/intrasense.fr\/?page_id=7066"},"modified":"2025-03-20T12:46:49","modified_gmt":"2025-03-20T11:46:49","slug":"legal-information-intrasense-products","status":"publish","type":"page","link":"https:\/\/intrasense.fr\/zh-hans\/legal-information-intrasense-products\/","title":{"rendered":"Legal information - Intrasense products"},"content":{"rendered":"\n
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Legal information - Myrian\u00ae<\/h2>\n\n\n\n

Myrian\u00ae 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.<\/p>\n\n\n\n

Myrian\u00ae 2.13 carries the CE 0459 mark in accordance with the requirements of;regulation 745\/2017 on medical devices.<\/p>\n\n\n\n

As Myrian\u00ae 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\u00ae XP-Prostate option AI available with Myrian\u00ae 2.13 is an AI option of the variant Myrian\u00ae XP-Prostate.
Myrian\u00ae XP-LungNodule option AI available with Myrian\u00ae 2.13 is an AI option of the variant Myrian\u00ae XP-LungNodule.<\/p>\n\n\n\n

Intrasense\u00ae and Myrian\u00ae 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).<\/p>\n\n\n\n

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Legal information - Liflow\u00ae<\/h2>\n\n\n\n

Liflow\u00ae 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.<\/p>\n\n\n\n

Liflow\u00ae 2.0 carries the CE 0459 mark in accordance with the requirements of regulation 745\/2017 on medical devices.
As Liflow\u00ae 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.<\/p>\n\n\n\n

A new version of Liflow\u00ae 3.0 is under developpement.<\/p>\n\n\n\n

Intrasense\u00ae and Liflow\u00ae 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).<\/p>\n\n\n\n

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Legal information - DUOnco\u2122<\/mark><\/h2>\n\n\n\n

DUOnco\u2122 Liver and DUOnco\u2122 Bone, Class II medical devices, are developed, manufactured and distributed by Intrasense SA. DUOnco\u2122 Liver is software designed to facilitate the analysis and review of contrast-enhanced CT images (portal phase) containing the liver through the automatic detection and measurement of liver lesions. DUOnco\u2122 Bone is software designed to facilitate the analysis and review of CT images by automatic detection of bone lesions. DUOnco\u2122 Liver and DUOnco\u2122 Bone bear the CE mark 0459 in accordance with the requirements of Regulation 745\/2017 on medical devices. These medical devices are not approved by the FDA.<\/p>\n\n\n\n

As DUOnco\u2122 Liver and Bone are medical devices, not reimbursable, they are intended for use by healthcare professionals only. Precautions for use must be implemented, consult the instructions for use for further information.<\/p>\n\n\n\n

The DUOnco\u2122 Pancreas algorithm is a product under development, to be used for presentation or demonstration purposes only.<\/p>\n\n\n\n

Intrasense\u00ae and DUOnco\u2122 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).<\/p>\n\n\n\n

Translated with DeepL.com (free version)<\/p>\n\n\n\n

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Legal information - icobrain<\/strong><\/mark><\/h2>\n\n\n\n

icobrain<\/strong> is a medical device intended to be used by healthcare professionals only. The intended purposes of each software are listed below:<\/p>\n\n\n\n

icobrain mr<\/strong> 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<\/strong> consists of two distinct image processing pipelines: icobrain mr <\/strong>cross and icobrain mr <\/strong>long.<\/p>\n\n\n\n