Eu Mdd Eu Md Class 2a On The Market πŸ‡¨πŸ‡³ China

AngioPlus Core

Shanghai Pulse Medical Technology, Inc. Β· πŸ‡¨πŸ‡³ China
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1

Basic Information

Primary DI
16974687731322
Basic UDI-DI Code
B-16974687731322
Reference
NA
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

AngioPlus Core is a post-processing image analysis software developed for the clinical quantitative and qualitative analysis of XA images. 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 clinician in the assessment of coronary artery disease and planning of the interventional surgery. AngioPlus Core is independent of imaging equipment, imaging protocols and equipment vendors. The analysis results obtained with AngioPlus Core 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.

CND Nomenclature Codes

Code Description
Z129092 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE

Certificates

Type Number
MDD Annex II (excluding section 4) CE713430

Available In Countries

πŸ‡ͺπŸ‡Έ Spain

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