CorEx

Organization name

Spimed-AI

SRN

FR-MF-000036589

Manufacturer status

Active

Primary placement in France; available across 5 countries total.

Trade name

CorEx

UDI-DI code

G532CMD0E

Basic UDI-DI

B-G532CMD0E

Reference / catalog number

N/A

Issuing entity

HIBCC

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12059082VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - SOFTWARE ACCESSORIES

• Batch number
• Expiration date
• Manufacturing date
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This device is not currently linked to any other device.