Medis Suite MRCT

Organization name

Medis Medical Imaging Systems bv

SRN

NL-MF-000002670

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

Primary placement in Netherlands; available across 20 countries total.

Trade name

Medis Suite MRCT

UDI-DI code

MEDISSUITEMRCT2023

Basic UDI-DI

B-MEDISSUITEMRCT2023

Reference / catalog number

20240115

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Medis Suite MRCT consisting of QMass, QFlow, 3DView, QFlow 4D and QStrain and is the Medis' software solution for the analysis of cardiac MRI and CT studies. Assisted by their automatic contour detection, QMass and QFlow provide quantitative analyses quickly and accurately. QMass includes the analysis of cardiac dimensions and function, myocardial perfusion, and myocardial viability. QFlow adds the accurate analysis of blood flow based on velocity encoded cine MRI. 3DView can be used for the visualization and analysis of MR images of the heart and blood vessels. QFlow 4D supports the 3D visualization and 2D quantification analysis of 4D flow MR studies. It enables cardiologists, radiologists, and technicians to quantify arterial and transvalvular blood flow. QStrain is used to quantify myocardial deformation (strain) in cardiac MR studies.

Additional information URL

https://www.medisimaging.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

MEDISSUITEMRCT2023

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12050582CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES