Green X 21 (PHT-90CHO)
VATECH Co., LtdGreen X 21 (PHT-90CHO) is an advanced 6-in-1 digital dental X-ray system that combines multiple imaging modalities including panoramic, cephalometric, and 3D CT scans for diagnostic details of dento-maxillofacial, sinus, TMJ, and ENT regions. It helps clinicians by providing comprehensive imaging from one device to improve diagnosis and treatment planning, especially for adult and pediatric dental and ENT patients.
Intended Use
Green X 21 (Model: PHT-90CHO) is intended to produce panoramic, cephalometric, or 3D digital X-ray images providing diagnostic details of dento-maxillofacial, sinus, TMJ, and ENT for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment.
Technology
Green X 21 is a 6-in-1 digital X-ray system with six imaging modalities: PANO, CEPH (optional), Dental CT, ENT CT, MODEL, and FACE SCAN. It uses digital TFT detectors with new X-ray detectors for CT/PANO and CEPH modalities, and includes metal artifact reduction algorithms. It integrates advanced software functions such as Auto Pano, Smart Focus, and Scout modes for enhanced image acquisition and reconstruction.
Performance
Performance testing included non-clinical and clinical equivalence tests, image quality evaluations, and dosimetric comparisons. New detectors demonstrated equivalent or superior performance in modulation transfer function, detective quantum efficiency, and noise power spectrum. The device met IEC standards for image quality and safety, with software validation and electrical, mechanical, and EMC safety testing also passing all required standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
4 months - 2
FDA Approval
2/14/2025
Other devices from VATECH Co., Ltd
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.