Coronary Analysis System
Basic Information
- Primary DI
- 06971381280210
- Basic UDI-DI Code
- B-06971381280210
- Reference
- Class Ⅱa
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Suzhou RainMed Medical Technology Co., Ltd.
Additional Description
The Coronary Analysis System is intended to quantitatively calculate the Coronary Angiography Fractional Flow Reserve (CAFFR) in coronary artery stenosis by conducting vascular segmentation and three-dimensional reconstruction on coronary angiography images (conforming with DICOM3.0 standard) and hemodynamic analysis combing with the aortic pressure measured by disposable blood pressure transducer. It is intended to be used for functional evaluation of coronary artery lesions in adult patient by qualified medical technicians. In clinical practice, coronary artery vessels should be comprehensively evaluated combining with the clinical history, symptoms, other diagnostic results of patients and the professional judgment of clinicians.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C0104010199 | CARDIAC ANGIOGRAPHY DIAGNOSTIC DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 705664 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).