Green X 21 (PHT-90CHO)

The Green X 21 (PHT-90CHO) is a 6-in-1 digital X-ray system for dental radiography that produces panoramic, cephalometric, and 3D CT images for diagnostic evaluation of dento-maxillofacial, sinus, TMJ, and ENT regions in adult and pediatric patients. It also captures carpal images for orthodontic treatment planning and includes an optional face scanner for aesthetic consultation overlays. The device is operated by healthcare professionals.

The subject device uses new X-ray detectors (Jupi1012X for CT/PANO and Venu1012VD for CEPH) compared to the predicate's detectors, resulting in different maximum fields of view and a one-shot imaging capture method for CEPH. It adds two new modalities (ENT CT and FACE SCAN) and three new software functions (Auto Pano, Smart Focus, Scout). The X-ray source, tube voltage/current, filtration, image viewers (EzDent-i, Ez3D-i), and reconstruction algorithms remain identical to the predicate.

Testing followed 21 CFR Parts 1020.30, 1020.31, 1020.33; IEC 61223-3-5 (CT acceptance and imaging performance); IEC 61223-3-4 (dental X-ray acceptance); IEC 60601-1:2005+AMD, IEC 60601-1-3:2008+AMD, IEC 60601-2-63:2012+AMD (electrical and safety); and IEC 60601-1-2:2014+AMD (EMC). Performance was assessed using Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE), and Noise Power Spectrum (NPS) metrics.

Substantial equivalence is established because: (1) the subject device maintains identical indications for use, X-ray source specifications, materials, and safety characteristics as the predicate; (2) new detectors demonstrated equivalent or superior performance in DQE, MTF, and NPS metrics with no aliasing artifacts; (3) the new ENT CT modality adheres to the same image quality standards as existing Dental CT; (4) FACE SCAN is non-diagnostic and does not require X-ray exposure; (5) Auto Pano, Smart Focus, and Scout functions were already cleared in predicate device K231796; and (6) overall image quality testing confirmed equivalent or better diagnostic performance across PANO, CEPH, and CT modalities.