RefleXion Medical Radiotherapy System, Reflexion X2

The RefleXion X2 is a hybrid imaging and radiation therapy system that combines PET imaging, CT imaging, and a linear accelerator to deliver image-guided and biology-guided radiation therapy. It treats tumors anywhere in the body using conventional CT-guided approaches or FDG-guided biology-guided radiotherapy (BgRT) in five or fewer fractions, with the system detecting F18 signals during beam delivery to guide dose delivery.

The X2 System expands the PET subsystem's axial field of view from 5.3 cm to 21.5 cm using four detector rows instead of one, integrates onboard GPUs for improved image processing, and updates the kVCT subsystem with a new X-ray tube and generator. It also adds usability features including automatic image registration, a PET intrafraction image viewer, and integrated multi-target workflow tools. These enhancements do not alter the core radiation delivery technology or safety profile compared to the predicate X1 System.

Testing per IEC 60601 series (medical electrical equipment safety), ISO 14971 (risk management), IEC 62304 (software life cycle), IEC 62366-1 (usability engineering), IEC 60976 (electron accelerators), IEC 61217 (radiotherapy equipment coordinates), IEC 62083 (treatment planning systems), and NEMA NU-2 (PET performance measurements).

The RefleXion X2 shares the same intended use, indications, clinical workflow, and principles of operation as the predicate RefleXion X1 System. Design enhancements improve performance and usability but do not introduce new patient-contacting materials, contamination pathways, or safety risks. Non-clinical bench testing, validation studies, and usability testing with representative users confirmed that all critical tasks are safe and effective, and no new questions of safety or effectiveness are raised by the differences.