RCT700
Ray Co., Ltd.The RCT700 is a dental CBCT (cone beam computed tomography) and panoramic X-ray imaging system with an optional cephalometric feature. It is intended for radiographic examination of the dento-maxillofacial area, sinuses, TMJ, airway, and ENT structures for both adult and pediatric patients. The device helps dentists and other qualified health professionals obtain high-quality 3D and 2D images to assist in diagnosis and orthodontic treatment assessment.
Intended Use
RCT700 is a CBCT and panoramic x-ray imaging system with cephalometric. It is intended for radiographic examination of the dento-maxillofacial, sinus, TMJ, airway and ENT structures for diagnostic support in adult and pediatric patients. It includes a model scan option and wrist imaging for growth and maturity assessment in orthodontics.
Technology
The device rotates a C-arm housing a high-voltage generator, X-ray tube, and detectors to obtain CBCT images by recombining data from multiple angles. It supports panoramic and cephalometric imaging options. The software saves patient/image data, supports image generation from sensors, and provides inquiry functions. Detectors for CT, panoramic, and cephalometric scans are included. The device is DICOM compatible and uses specific detectors such as FXDD-0606CA and Jupi0606X1 for CT and panoramic imaging.
Performance
The device underwent non-clinical benchtop performance testing following FDA guidance and IEC standards for imaging properties, patient dosage, safety, EMC, and software validation. Clinical imaging samples were reviewed by licensed practitioners confirming image quality suitable for intended diagnostic uses. The software was validated for safety and effectiveness, considered low risk.
Predicate Devices
No predicate devices specified
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