Cuattro Medical

Cuattro Medical specializes in two primary categories of medical devices: radiological PACS (Picture Archiving and Communication Systems) software, which digitizes, stores, and manages medical imaging data, and stationary basic diagnostic X-ray systems designed for capturing digital X-ray images in clinical environments. These devices support workflows in radiology and diagnostic settings.

Cuattro Medical is based in the United States, and its devices are primarily regulated within the U.S. regulatory framework. This is reflected in the company’s focus on compliance with FDA requirements, including the listing of specific devices in the FDA’s Unique Device Identifier (UDI) database.

Cuattro Medical’s devices are classified as Class II medical devices. This classification applies to products that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as radiological imaging systems and PACS software, which require validation for proper functionality and compliance with imaging standards.

Yes, Cuattro Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify the identity and regulatory status of specific devices like CuattroDR and CloudDR™.