Green X 12 SE (PHT-40CHS)
VATECH Co., LtdThe Green X 12 SE (PHT-40CHS) is a 4-in-1 advanced digital X-ray system for dental imaging that combines panoramic, cephalometric, 3D Cone Beam CT (CBCT) and model scanning capabilities in one device. It helps dentists and healthcare professionals provide detailed diagnostic images of the head, neck, and dental structures, supporting accurate diagnosis and treatment planning for adult and pediatric patients, including orthodontics. This device enhances imaging workflow and diagnostic capabilities by integrating multiple imaging modalities with modern digital detectors and software.
Intended Use
Green X 12 SE (Model : PHT-40CHS) is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus, and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.
Technology
Green X 12 SE (PHT-40CHS) is a digital 4-in-1 X-ray imaging system combining PANO, CEPH (optional), CBCT, and MODEL Scan imaging capabilities. It uses a CMOS digital X-ray detector and Ethernet communication for detector data transmission. The device integrates imaging viewers, an X-ray generator, and a dedicated SSXI detector. It shares materials, X-ray source, and image reconstruction algorithms (including Metal Artifact Reduction) with its predicate, differing by detector communication method and some hardware changes.
Performance
Non-clinical performance testing includes laboratory testing comparing image quality metrics (contrast, noise, CNR, MTF) between subject and predicate devices using FDK and CS reconstruction algorithms, demonstrating equivalent image quality. Dosimetric performance was evaluated via DAP measurements under identical exposure conditions, showing similar dose performance. Safety and EMC testing conform to relevant IEC standards. Software verification and validation were performed per FDA guidelines. The device demonstrated substantial equivalence with the predicate device for safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
4 months - 2
FDA Approval
2/21/2025
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