RCT600

The RCT600 is a cone-beam computed tomography (CBCT) and panoramic x-ray imaging system with optional cephalometric capability. It is intended for radiographic examination of dental, maxillofacial, sinus, and temporomandibular joint (TMJ) structures in adult and pediatric patients, and includes wrist/carpus imaging for growth assessment in orthodontic treatment. The device is operated by dentists or other legally qualified healthcare professionals.

The RCT600 uses the same detectors (Jupi0606X1 for CT and panoramic, Pluto0900X for scan cephalometric) and core x-ray parameters (60–100 kVp, 1–17 mA, minimum 2.8 mm Al filtration) as the predicate RCT700. Key differences are: deletion of the one-shot cephalometric option, increased magnification for CT (1.55 vs 1.44) and panoramic (1.44 vs 1.31) modes, slightly increased scan times (CT to 20 sec, ceph scan to 17.6 sec), and a different image viewing software (SMARTScam vs RayScan).

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 (electrical, mechanical, and environmental safety); IEC 60601-1-2:2014+AMD1:2020 (EMC); IEC 61223-3-4 and IEC 61223-3-7 (imaging performance). FDA guidance documents on solid-state x-ray imaging devices, device software functions, and cybersecurity were also referenced.

The RCT600 is substantially equivalent because it shares the same intended use, imaging modalities (CBCT, panoramic, cephalometric), detector components, and x-ray source characteristics as the predicate RCT700. The differences—removal of one-shot cephalometry, altered magnification, and modified scan times—do not affect safety or effectiveness; imaging performance testing (MTF, DQE, NPS) showed no significant differences, and clinical testing by a licensed practitioner confirmed diagnostic image quality. Software changes are minor (viewing software only) and classified as basic-level concern; bench testing confirmed adequate x-ray parameters for diagnostic imaging.