Basic Information
- Primary DI
- G532CMD0E
- Basic UDI-DI Code
- B-G532CMD0E
- Reference
- N/A
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Spimed-AI
Additional Description
CorEx is a standalone software that is intended to be used for viewing and analyzing cardiac computed tomography (CT) data in support for the evaluation of coronary artery disease (CAD). This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides visualization of CT scan images, classification of coronary lesions according to their degree of severity (using the international CAD-RADS classification) and can, in the event of a lesion, infer their functional character by estimating the coronary flow reserve (FFR-AI) using artificial intelligence. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of CorEx are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12059082 | VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - SOFTWARE ACCESSORIES |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDD).