Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)

The Green X 12 VE and Green X VE are 4-in-1 digital X-ray systems for dental imaging. They produce panoramic, cephalometric, and 3D cone-beam computed tomography images to provide diagnostic details of the dento-maxillofacial, sinus, and TMJ regions in adult and pediatric patients, and also capture carpal images for orthodontic treatment planning.

Both devices use the same D-052SB X-ray source, 60–99 kV tube voltage, 4–16 mA tube current, 0.5×0.5 mm focal spot, and identical mechanical and electrical design (LDCP logic circuit). Green X 12 VE differs by using Xmaru1404CF-PLUS Eth and Xmaru2602CF Eth detectors with Ethernet communication instead of optical. Green X VE uses the smaller Jupi0606X1 detector (180×100 mm FOV) versus the predicate Jupi1012X (210×190 mm FOV). Both incorporate updated viewing software EzDent-i (K241114) and Ez3D-i (K231757).

Testing followed 21 CFR 1020.30, 1020.31, 1020.33; IEC 61223-3-7:2021 (dental CBCT acceptance tests); IEC 61223-3-4:2000 (dental X-ray acceptance tests); IEC 60601-1:2005+AMD1:2012+AMD2:2020 (medical device safety); IEC 60601-1-2:2014+AMD1:2020 (EMC); and NEMA PS 3.1-3.18 (DICOM).

The subject devices are substantially equivalent because they share identical intended use, X-ray source, tube specifications, mechanical design, and image reconstruction including metal artifact reduction algorithms with their predicates. New detectors (Xmaru1404CF-PLUS Eth, Xmaru2602CF Eth, Jupi0606X1) were validated via non-clinical performance testing demonstrating equivalent or superior DQE, MTF, NPS, and NED. Detector communication changes (optical to Ethernet) and smaller FOV in Green X VE do not compromise safety or diagnostic performance. Updated viewing software remains within FDA-cleared functionality scope.