mdprostate - cluster

Primary DI

04260737640061

Basic UDI-DI Code

426073764PRS01C9

Reference

006

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

mediaire GmbH

The product is intended for semi-automatic labeling, visualization and volumetric quantification of 3D MRI data (in DICOM format) of the prostate. The software automates the currently manual process of identifying, labeling and volumetric calculation of segmented prostate structures on 3D MRI images. The calculated volumetric data, in addition to the image data at hand, can assist trained medical professionals in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using mdprostate.

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).