Philips Digital Mammography Sweden AB

Philips Digital Mammography Sweden AB specializes in stationary digital mammographic X-ray systems, such as the MicroDose SI series, which are used for breast cancer screening and diagnostic imaging. They also produce fixed-aperture diagnostic X-ray system collimators, like the Collimator Cradle 512 asm, designed to enhance imaging precision and reduce radiation exposure during procedures.

The company is based in the United States, which means its devices must comply with U.S. regulatory standards. Since its products fall under Class II classification, they are subject to specific controls, including premarket notifications (510(k)) and Unique Device Identifier (UDI) requirements, ensuring traceability and safety in the market.

The company’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The 510(k) registry demonstrates that each device has undergone a premarket submission process to confirm safety and effectiveness compared to predicate devices. The UDI system ensures standardized identification, improving tracking, recall management, and regulatory oversight.

The company’s devices are classified as Class II, which means they pose moderate risk and require special controls beyond general controls to ensure safety and performance. This classification necessitates compliance with FDA regulations, including pre-market notifications (510(k)) and ongoing post-market surveillance, ensuring continuous monitoring of device performance and safety.