mdbrain - cluster

Primary DI

04260737640047

Basic UDI-DI Code

426073764mbV4MB

Reference

004

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

mediaire GmbH

The product is intended for automatic labeling, visualization and volumetric quantification of 3D MRI data (in DICOM format) of the head. The software automates the currently manual process of identifying, labeling and volumetric calculation of segmented brain structures on 3D MRI images. The calculated volumetric data, in addition to the image data at hand, can assist radiologists in detecting neurological diseases. The volumetric data obtained alone is not sufficient to establish a diagnosis and is not intended to do so.

The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).