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
- Manufacturer
- Yukun (Beijing) Technology Co., Ltd.
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
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