RCT600
RAY Co., Ltd.The RCT600 is a dental and maxillofacial imaging system that uses cone beam computed tomography (CBCT), panoramic, and cephalometric X-ray imaging to help dentists and healthcare professionals diagnose and plan treatment for both adult and pediatric patients. It produces high-quality 3D and 2D images of hard tissues like bones and teeth, as well as wrist images for orthodontic growth assessment, enabling better clinical decisions and patient care.
Intended Use
RCT600 is CBCT and panoramic x-ray imaging system with cephalometric. It is intended for radiographic examination of the dento-maxillofacial, sinus and TMJ structures, with wrist imaging for growth and maturity assessment in orthodontic treatment for adult and pediatric patients. The device is to be operated by dentists or other legally qualified health care professionals.
Technology
The RCT600 uses a rotating C-arm that houses a high-voltage generator, x-ray tube, and detector to obtain CBCT images by recombining data scanned from different angles. It also supports panoramic and cephalometric imaging modes. The image reconstruction and acquisition use the same underlying technology as its predicate device, but with modifications such as removal of the one-shot cephalometric option, different detector, and updated image viewing software.
Performance
The device underwent electrical, mechanical, environmental, and EMC safety testing according to multiple IEC standards. Software was validated per FDA guidance for device software functions and cybersecurity. Bench and clinical testing demonstrated image quality metrics (MTF, DQE, NPS) comparable to its predicate device. Clinical images reviewed by a licensed practitioner confirmed diagnostic quality, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/19/2024
2 months - 2
FDA Approval
3/12/2025
Other devices from RAY Co., Ltd.
- SMARTDent2025 • 510K
- RAYDENT SW2024 • 510K
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