PROTON SYSTEMS VIRGINIA LLC

Proton Systems Virginia LLC specializes in radiation therapy beam block materials, which are critical components used in proton therapy. These devices shape and modulate proton beams to precisely target tumors during cancer treatment, helping to minimize exposure to surrounding healthy tissue. The focus is on ensuring accurate delivery in high-precision radiation oncology settings.

Proton Systems Virginia LLC is headquartered in the United States. This location means its devices are subject to U.S. regulatory requirements, including classification under the FDA’s system. The company’s products are designed and manufactured with compliance in mind, adhering to standards relevant to radiation therapy equipment in the U.S. market.

Proton Systems Virginia LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers, regulators, and patients. Listing in the UDI database is a requirement for Class II devices like those produced by the company.

Proton Systems Virginia LLC’s devices fall under FDA Class II classification. This classification is assigned based on the level of control needed to ensure the device’s safety and effectiveness. Class II devices typically require special controls beyond general controls (like good manufacturing practices) to mitigate potential risks, such as those associated with precision radiation delivery in cancer treatment.