THE SMARTXRAY, LLC

The Smartray® GLX 0.1 is a medical device designed to assist healthcare professionals in achieving precise and consistent patient head positioning during weight bearing X-ray imaging studies for the purpose to assess major stabilizing ligaments in the Cervicocranial Junction (CCJ) in general population suffering from whiplash injuries causing upper quarter chronic pain. The system provides real-time, AI-generated visual guidance to support head alignment. The final positioning and X-ray exposure decisions remain solely with the healthcare provider. The device does not modify or control the X-ray machine, nor does it interpret or analyze medical images for diagnostic purposes. Indication for Use: Smartray® GLX 0.1 provides real-time, AI-assisted visual guidance to support consistent and precise head positioning during weight-bearing X-ray imaging studies to assess major stabilizing ligaments in the Cervicocranial Junction (CCJ). The system assists healthcare professionals in creating, directing, maintaining and storing alignment but does not physically touch the patient for stabilizing or controlling head movement. Manufacturer: The Smartxray, LLC 6267 Isla Verde Ave, 9R, Carolina, PR 00979, USA