Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
VATECH Co., Ltd.Green X 12 VE (PHT-70CHS) and Green X VE (PHT-70CHS) are dental CT X-ray systems designed to provide detailed panoramic, cephalometric, and 3D images of dento-maxillofacial, sinus, and TMJ regions, including carpal images for orthodontic treatment. They help healthcare professionals diagnose and treat dental and maxillofacial conditions, integrating multiple imaging modalities into one device.
Intended Use
PHT-70CHS is intended to produce panoramic, cephalometric, or 3D digital x-ray images providing diagnostic details of the dento-maxillofacial, sinus, and TMJ for adult and pediatric patients. The system also uses carpal images for orthodontic treatment.
Technology
The device is a 4-in-1 digital X-ray system combining panoramic, optional cephalometric, dental CT and model imaging. It includes an X-ray generator, dedicated image receptors, and compatible software for 2D and 3D image acquisition and reconstruction with metal artifact reduction algorithms. Two configurations differ in CT and panoramic image receptors.
Performance
Non-clinical lab tests compared new X-ray detectors to predicates in terms of Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE), Noise Equivalent Dose (NED), and Noise to Power Spectrum (NPS), showing equivalent or better diagnostic image quality and safety. Quantitative image quality tests, dose performance evaluations, and software verifications were done. The device passed relevant IEC and FDA guidance standards, demonstrating substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
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