RCT800

The RCT800 is a dental cone beam computed tomography (CBCT) and panoramic x-ray imaging system with optional cephalometric capabilities. It is intended for radiographic examination of dento-maxillofacial, sinus, TMJ, and airway structures for diagnostic support in adult and pediatric patients, and includes optional model scanning and wrist/carpus imaging for orthodontic growth assessment. The device is operated by dentists or other legally qualified healthcare professionals.

The RCT800 is substantially the same as the predicate device (K230753) with two key differences: (1) addition of new detectors including Mercu0810X1 and Pluto0900X for CT, panoramic, and scan cephalometric modes, and (2) software version upgrade from 1.1.0.0 to 1.2.0.0. All other technological parameters including X-ray voltage (60-100kVp), focal size (0.5), imaging modes (CBCT, panoramic, cephalometric), and mechanical design remain identical to the predicate device.

Testing was conducted per IEC 60601-1:2005/AMD1:2020, IEC 60601-1-3:2008/AMD1:2013/AMD2:2021, IEC 60601-1-6:2010/AMD1:2013/AMD2:2020, IEC 60601-2-63:2012/AMD1:2017/AMD2:2021, IEC 60601-1-2:2014+AMD1:2020 for EMC, IEC 61223-3-4 and IEC 61223-3-7 for imaging performance, and FDA guidance documents for solid-state x-ray imaging devices, software validation, and cybersecurity.

The RCT800 is substantially equivalent to predicate device K230753 because both devices share identical indications for use, fundamental technological architecture, imaging modes, X-ray parameters, and mechanical design. The new detectors are technologically similar components and the software upgrade maintains the same structure and function as the predicate. Comprehensive bench testing, performance testing, non-clinical and clinical evaluations using the same test protocols as the predicate demonstrate that differences do not affect safety or effectiveness.