Screenpoint Medical B.V.

Screenpoint Medical B.V. specializes in developing X-ray image interpretive software. These tools are designed to help radiologists analyze radiographic images, specifically focusing on assessing bone density and identifying fracture risks. The software automates parts of the interpretive process to support clinical decision-making.

Screenpoint Medical B.V. is based in the United States. The company’s headquarters and operations are located within the country, which is also where its medical devices are regulated and authorized.

Screenpoint Medical B.V.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries track devices that have undergone the required regulatory pathways, such as 510(k) clearance, to ensure compliance with U.S. medical device regulations.

Screenpoint Medical B.V.’s devices are classified as Class II medical devices under U.S. regulations. This classification applies to products that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. The company’s software falls under this category due to its role in interpreting radiographic images for clinical use.