5.17.z

Nom de l'organisation

icometrix

SRN

BE-MF-000006329

Statut du fabricant

Actif

Marché principal en Autriche ; disponible dans 24 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

+B621ICOBRAINMR5X17Y0

Basic UDI-DI

++B621ICOBRAINMREN

Numéro de référence/catalogue

5.17.z

Entité d'attribution

HIBCC

Catégorie de risque

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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. icobrain mr cross is intended to provide volumes from images acquired at a single timepoint 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.

URL des informations complémentaires

https://icobrain.icometrix.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

• Numéro de lot
• Date d'expiration
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• Numéro de série
• Identification du logiciel

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