ProBeam 360 Proton Therapy System v3.0

The ProBeam 360° Proton Therapy System v3.0 is a proton therapy device designed to deliver radiation treatment according to a physician's prescribed plan for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. It features an isochronous cyclotron with superconducting coils delivering protons at energies from 69–218 MeV via beam spot scanning through a 360° rotating gantry.

Major enhancements include unified software for both single- and multiroom configurations, introduction of Iterative Cone Beam CT (iCBCT) with scatter correction variants (iCBCT Acuros, iCBCT Acuros MAR), and the optional HyperSight package featuring extended field-of-view and short-arc CBCT modes. The underlying hardware, beam parameters, dose rate, and patient positioning system remain unchanged from the predicate devices.

Testing followed FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System, ISO 14971 Risk Management, IEC 62304 Software Life Cycle Process, and FDA recognized consensus standards for electrical safety and electromagnetic compatibility. Image quality testing used IEC and AAPM imaging guidance and internal design requirements.

The device has identical intended use and indications for use as the predicate devices (ProBeam 360° v1.0 and v2.0). All differences are enhancements to imaging capabilities aimed at improving image quality and clinical performance without changing the principle of operation. Verification and validation testing demonstrated that all new imaging modes met predefined acceptance criteria and did not introduce new risks.