EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC

Epiphany Healthcare Data Management, LLC specializes in cardiology information system application software. These devices are designed to manage, store, and integrate cardiac imaging and diagnostic data, helping to automate workflows and improve interoperability between imaging tools and clinical systems. The focus is primarily on electrophysiology and cardiac imaging environments, ensuring seamless data handling for healthcare providers.

Epiphany Healthcare Data Management, LLC is based in the United States. Since its devices fall under U.S. medical device regulations, they must comply with the relevant laws and standards set by the FDA. This includes registration, listing, and adherence to classification rules specific to the U.S. market, such as the requirement for a Unique Device Identifier (UDI) for traceability and tracking.

Epiphany Healthcare Data Management, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps ensure device traceability, reduces medical errors, and supports regulatory compliance by providing a standardized identifier for each distinct device. This listing is critical for tracking and managing the company’s Class II cardiology information system software in the U.S. market.

Epiphany Healthcare Data Management, LLC’s devices are classified as Class II under U.S. medical device regulations. Class II devices generally pose moderate risk and require special controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or labeling requirements. The classification ensures that the company’s cardiology information system software meets the necessary regulatory standards before being used in clinical settings.