Protom International Holding Corporation

Protom International Holding Corporation specializes in proton therapy systems, which are advanced medical devices used for cancer treatment. These systems, such as the Radiance 330 and Radiance 330 Proton Beam Therapy System, are designed to deliver precise proton radiation to tumors while sparing healthy tissue. This precision is particularly valuable for treating complex or sensitive cases where traditional radiation therapy may be less effective.

Protom International Holding Corporation is based in the United States. Since it operates within the US, its devices are subject to FDA regulations. The company’s products fall under Class II medical device classification, which typically requires premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device. This classification reflects a moderate level of risk, where general controls alone are insufficient to ensure safety and effectiveness.

Protom International Holding Corporation’s devices are listed in the FDA’s 510(k) registry, which tracks premarket notifications for Class II medical devices to demonstrate compliance with regulatory requirements. Additionally, the company’s devices appear in the FDA’s Unique Device Identifier (UDI) system, a standardized system for identifying medical devices throughout their distribution and use. These registries help ensure traceability and regulatory oversight of the devices in the market.

Protom International Holding Corporation’s devices are classified as Class II under US regulations. This classification indicates that while the devices pose a moderate risk, they require special controls in addition to general controls to ensure safety and performance. The special controls for Class II devices often include performance standards, post-market surveillance, or labeling requirements. This classification influences the regulatory pathway, such as the 510(k) process, which ensures the device meets necessary safety and effectiveness criteria before entering the market.