MRI- FLOW ANALYTICAL SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

ORTHO-CMS

FDA 510(k)

FDA Class 2 ·Radiology

QBRAIN

FDA 510(k)

FDA Class 2 ·Radiology

QPLAQUE MR

FDA 510(k)

FDA Class 2 ·Radiology

MRA-CMS

FDA 510(k)

FDA Class 2 ·Radiology

CT-MASS

FDA 510(k)

FDA Class 2 ·Radiology

QANGIO CT

FDA 510(k)

FDA Class 2 ·Radiology

QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS

FDA 510(k)

FDA Class 2 ·Radiology

QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW

FDA 510(k)

FDA Class 2 ·Radiology

QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)

FDA 510(k)

FDA Class 2 ·Radiology

MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

X-RAY VVA

FDA 510(k)

FDA Class 2 ·Radiology

MR-CT VVA

FDA 510(k)

FDA Class 2 ·Radiology

QCU ANALYTICAL SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

RSA-CMS

FDA 510(k)

FDA Class 2 ·Radiology

Medis Medical Imaging Systems bv

Manufacturer

🇳🇱 Netherlands·4 Basic UDI-DIs·4 Devices·SGS Belgium NV and SGS Belgium NV

Medis Suite MRCT

Device

EU MDD · Eu Md Class 2a ·Medis Medical Imaging Systems bv·On the market·20 countries

Medis Suite

Device

EU MDD · Eu Md Class 2a ·Medis Medical Imaging Systems bv·On the market·19 countries

QFR

Device

EU MDR · Eu Md Class 2a ·Medis Medical Imaging Systems bv·On the market·18 countries