Eu Mdr Eu Md Class 2a On The Market 🇨🇳 China

Careverse CoronaryDoc

Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0

Basic Information

Primary DI
06974183380416
Basic UDI-DI Code
6974183382aCON0035C
Reference
CKCZ3015
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

Intended use: Careverse CoronaryDoc is intended for the display and processing of Coronary Computed Tomography Angiography (CCTA) images, identification and display of coronary artery stenosis, as well as recognition of plaque, stent, and myocardial bridging. It assists in the diagnosis of stenosis severity in patients with coronary heart disease. It is intended for use by trained and qualified physicians and should not be used as sole evidence for clinical decision-making.

CND Nomenclature Codes

Code Description
Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE

Available In Countries

🇩🇪 Germany

Similar Devices

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

View all