5.17.z

Organization name

icometrix

SRN

BE-MF-000006329

Manufacturer status

Active

Primary placement in Austria; available across 24 countries total.

Trade name

not provided

UDI-DI code

+B621ICOBRAINMR5X17Y0

Basic UDI-DI

++B621ICOBRAINMREN

Reference / catalog number

5.17.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.

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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