CT-μFR

Primary DI

06974687731622

Basic UDI-DI Code

697468773CT01RQ

Reference

NA

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Shanghai Pulse Medical Technology, Inc.

CCTA-Derived Fractional Flow Reserve Analysis Software (hereinafter referred to as “CT-μFR”) is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. CT-μFR value is calculated from the simulated pressure and blood flow information which obtained from the 3D model. The CT- μFR value reflect the coronary blood flow reserve based on CCTA images, so this analysis is intended to support the functional evaluation of coronary artery disease. The software displays coronary anatomy and functional information using graphics and text, including computed and derived quantities of percent stenosis, blood flow and pressure, to aid the clinician in the assessment of coronary artery disease. The CtaPlus Analysis is performed on previously physician-acquired image data and is unrelated to acquisition equipment and clinical

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