Cardiolens Platform Intended Use

The Cardiolens Platform is a cloud-based software solution designed to securely manage and process medical data related to cardiovascular imaging studies without controlling or altering the functions or parameters of any connected medical devices. It enables authorized users to upload, store, organize, manage, and access patient data from Coronary Computed Tomography Angiography (CCTA) scans while providing robust control over user access and data security.

The functionalities of the Cardiolens Platform include:

• User Management: Enables the creation, suspension, and management of user accounts with defined roles and permissions to access specific data sets.

• Data Management: Provides tools for secure transmission, storage, management, and deletion of patient medical data.

• Process Management: Supports the organization and management of the data processing workflow.

• Monitoring & Audit Log: Maintains a comprehensive audit log to track data access, modifications, and other activities within the system, ensuring transparency and accountability.