6.16.z

Organization name

icometrix

SRN

BE-MF-000006329

Manufacturer status

Active

Primary placement in Austria; available across 9 countries total.

Trade name

not provided

UDI-DI code

+B621ICOBRAINMR6X16Y0

Basic UDI-DI

++B621ICOBRAINMREN

Reference / catalog number

6.16.z

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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. As input, icobrain mr uses 3D T1-weighted, 3D or 2D (max 3 mm slice thickness) fluid-attenuated inversion recovery (FLAIR) and 2D T2* gradient echo (T2*-GRE) DICOM MR images from a single or from multiple time points. In case of multiple time points, i.e. multiple MRI scans from the same subject, for each time point one FLAIR, T2*-GRE and one T1 image are used as input. During the pre-processing, the scan type (T1, FLAIR, T2*-GRE) is detected for every input image before it is converted from DICOM format to NIFTI format. The image processing then performs the actual segmentation and calculates the volumes of the brain structures. In case MRI scans from the same subject on multiple time points are available, the changes in volume of the brain structures are calculated as well. Finally, the computed volumes and volume changes (in case of multiple time points) are summarized into an electronic report and (some) segmentations are overlaid on the input images.

Additional information URL

https://icobrain.icometrix.com/

Clinical sizes

No clinical sizes registered for this device.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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