UFR

Primary DI

06974687731516

Basic UDI-DI Code

697468773IVUS015Z

Reference

NA

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Shanghai Pulse Medical Technology, Inc.

IvusPlus is a post-processing image analysis software developed for the clinical quantitative and qualitative analysis of IVUS data. It is an analysis tool to assess profile and function of the coronary arteries.The software provides functional information using graphics and text, including calculated and derived quantities of blood flow, lumen and side-branch profile, 3D model, outputs quantitative UFR values and anatomical parameters, to aid the clinician in the assessment of coronary artery disease and planning of the interventional surgery.vusPlus is independent of imaging equipment, imaging protocols and equipment vendors.The analysis results obtained with IvusPlus are intended for use by cardiologists and researchers: • To provide quantitative results of coronary vessel segments; • To inform the clinical decision-making process with respect to the diagnosis and possible PCI treatment options of the coronary vessels; • To evaluate the procedural success of such coronary interventions.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).