Xstrahl, Ltd.

Xstrahl, Ltd. specializes in stationary orthovoltage therapeutic x-ray systems, which include floor-mounted and ceiling-mounted models with different output capacities (e.g., 100, 150, 200, and 300 units). Additionally, the company produces photoelectric therapy systems, such as the XBeam (v2) and X80/RADiant variants, designed for specific therapeutic treatments. These devices are primarily used in clinical settings for controlled radiation-based therapies.

Xstrahl, Ltd. is based in the United States. Its devices fall under U.S. regulatory oversight, specifically as Class II medical devices under FDA regulations. This classification typically means they pose moderate risks and require compliance with FDA requirements, including pre-market submissions like the 510(k) pathway for x-ray systems and UDI (Unique Device Identification) registration.

Xstrahl, Ltd.’s devices are recorded in the FDA’s 510(k) database, which tracks pre-market submissions for Class II medical devices like therapeutic x-ray systems. Additionally, its products are included in the FDA’s UDI (Unique Device Identification) system, ensuring traceability and compliance with U.S. medical device regulations. These registries help track authorized devices and their compliance status.

Xstrahl, Ltd.’s devices are classified as Class II medical devices by the FDA. This classification is based on their intended use—such as therapeutic x-ray systems or photoelectric therapy devices—which are deemed to have moderate risk. Class II devices require compliance with specific controls, including performance standards and post-market surveillance, but do not require pre-market approval (PMA) like higher-risk Class III devices.

Xstrahl’s photoelectric therapy systems (e.g., XBeam, X80/RADiant) are designed for targeted therapeutic treatments using photoelectric effects, which may involve lower-energy radiation or light-based modalities for conditions like skin cancer or inflammation. In contrast, its stationary orthovoltage x-ray systems (e.g., 100–300 units) are high-energy therapeutic x-ray devices used for deeper tissue treatments, such as radiation therapy for tumors. Both are Class II devices but serve distinct clinical applications.