GT300; GT300-C

The GT300 and GT300-C are diagnostic computed tomography X-ray systems designed to produce 2D panoramic/cephalometric and 3D cone beam CT images. They are used to capture diagnostic information for the dental-maxillofacial region, TMJ, sinuses, and carpal imaging in adult and pediatric patients for treatment planning.

The GT300 uses one detector (Mercu0707X) for panoramic/CT imaging, while GT300-C uses two detectors (Mercu0707X plus Extor-C for cephalometric). Both devices use the Theia image processing software. The emergency switch location and plastic enclosure design differ from the predicate device, but operating principle, input voltage, tube voltage/current, and focal spot size remain identical.

IEC 61223-3-7 (acceptance and constancy tests for dental CBCT), IEC 60601-1 (general safety and performance), IEC 60601-1-2 (electromagnetic disturbances), and IEC 60601-2-63 (dental extra-oral X-ray equipment requirements).

GT300 and GT300-C have identical indications for use, operating principles, and performance characteristics as the predicate device PAPAYA 3D Premium (K200469). Minor technical differences such as the new Mercu0707X detector and design changes have been successfully evaluated through safety and performance testing. Clinical image evaluation confirms image quality is substantially equivalent to the predicate device.