OFR

Primary DI

16974687731216

Basic UDI-DI Code

B-16974687731216

Reference

NA

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Shanghai Pulse Medical Technology, Inc.

OctPlus is an analysis software for the post-processing image, which is developed for the clinical quantitative and qualitative analysis of OcT 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, to aid the physician in the assessment of coronary artery disease and planning of the interventional surgery. OctPlus is independent of imaging equipment, imaging protocols and equipment vendors. The analysis results obtained with OctPlus are intended for use by cardiologists and researchers: To provide quantitative results of coronary vessel segments; To inform physicians about coronary vascular diagnoses and possible PCl treatment options in the clinical decision-making process; 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 MDD).