myray ProXIma X6

The myray ProXIma X6 is an extra-oral X-ray system for dental imaging that produces panoramic (2D), cephalometric (2D), and tomographic (3D CBCT) images of the maxillofacial area and oral cavity. It is used by physicians, dentists, and X-ray technologists for diagnostic dental examinations including teeth, dental arches, jaw structures, and optional hand (carpus) imaging when equipped with a cephalometric arm.

The ProXIma X6 features a rotating arm with X-ray source and detector that moves around the patient's head via motorized roto-translation movements. It uses either CMOS or IGZO TFT detectors for 2D imaging and Amorphous Silicon detectors for 3D CBCT. Tube voltage ranges from 60-90 kV (continuous for 2D, pulsed for 3D), tube current 2-16 mA, and exposure times 1-40 seconds. The device includes optional cephalometric arm and software (Neowise) for image acquisition, processing, and display.

Testing performed per IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-63 (X-ray systems), IEC 60825-1 (laser safety), IEC 61223-3-7 (bench testing of detectors), and IEC 62304 (medical device software). FDA guidance documents on solid-state X-ray imaging devices and cybersecurity in medical devices were also referenced.

The ProXIma X6 is substantially equivalent to the predicate device (hyperion X5, cleared as K200688) based on identical intended use, principle of operation, functional design, and established medical use for panoramic, cephalometric, and tomographic dental imaging. Minor differences in detector specifications, laser pointer count, and cephalometric arm design do not negatively affect substantial equivalence. Clinical and non-clinical testing demonstrated equivalent image quality and radiation safety.