008

Organization name

mediaire GmbH

SRN

DE-MF-000010713

Manufacturer status

Active

Primary placement in Austria; available across 3 countries total.

Trade name

not provided

UDI-DI code

04260737640085

Basic UDI-DI

426073764KNE017G

Reference / catalog number

008

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The product is intended for classification, visualization and volumetric quantification of MRI data (in DICOM format) of the knee. The software automates the currently manual process of identifying and classifying knee findings on MRI images. The determined classifications and schematics, in addition to the image data at hand, can assist trained medical professionals in the interpretation of knee MR studies. Diagnosis should not be made solely based on the analysis performed using mdknee.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z11059092VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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