Eu Mdd Eu Md Class 2a On The Market ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands

Medis Suite MRCT

Medis Medical Imaging Systems bv ยท ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands
Devices (same UDI-DI)
1
Certificates
1
Countries
20
Notified Bodies
1

Basic Information

Primary DI
MEDISSUITEMRCT2023
Basic UDI-DI Code
B-MEDISSUITEMRCT2023
Reference
20240115
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market

Additional 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.

CND Nomenclature Codes

Code Description
Z12050582 CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES

Certificates

Type Number
MDD Annex II (excluding section 4) BE19/819943785

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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