CT-μFR
Basic Information
- Primary DI
- 16974687731414
- Basic UDI-DI Code
- B-16974687731414
- Reference
- NA
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Shanghai Pulse Medical Technology, Inc.
Additional Description
CtaPlus is a post-processing image analysis software developed for the clinical quantitative and qualitative analysis of coronary CT angiography 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. CtaPlus is independent of imaging equipment, imaging protocols and equipmentd vendors. The analysis results obtained with CtaPlus are intended for use by cardiologists and researchers: (1) To provide quantitative results of coronary vessel segments; (2) To inform the clinical decision-making process with respect to the diagnosis and possible PCI treatment options of the coronary vessels.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z129092 | VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 713430 | BSI Group The Netherlands B.V. |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).