Green X 12 SE (PHT-40CHS)

The Green X 12 SE (PHT-40CHS) is a dental X-ray imaging system that produces panoramic, cephalometric, and 3D cone-beam computed tomography (CBCT) images for diagnostic evaluation of the dento-maxillofacial region, sinuses, and temporomandibular joint in adult and pediatric patients. It also captures carpal images for orthodontic treatment planning and must be operated by healthcare professionals.

The subject device uses Ethernet-based detectors (Xmaru1404CF-PLUS Eth and Xmaru2602CF Eth) instead of the predicate's optically-coupled detectors, replacing optical communication with Ethernet communication. The Double Scan feature has been removed, eliminating the associated chinrest motor and control panel switch design changed from capacitive keypad to membrane switch. All other specifications—X-ray source (D-052SB), tube voltage (60–99 kV), focal spot size (0.5×0.5 mm), slice width (0.1 mm minimum), imaging volume (120×85 mm), and reconstruction algorithms—remain identical to the predicate.

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Edition 3.2), IEC 60601-1-3:2008+AMD1:2013+AMD2:2021 (Edition 2.2), IEC 60601-2-63:2012+AMD1:2017+AMD2:2021 (Edition 1.2), IEC 60601-1-2:2014+AMD1:2020 (Edition 4.1), IEC 61223-3-4, IEC 61223-3-5, 21 CFR Parts 1020.30–1020.33, and NEMA PS 3.1–3.18 (DICOM).

The devices share identical indications for use, materials, safety characteristics, X-ray source, and image reconstruction/MAR algorithms. Both undergo the same performance testing protocol using FDK and iterative reconstruction; image quality metrics (contrast, noise, CNR, MTF) and dosimetric performance (DAP measurements) were equivalent under identical exposure conditions. The detector change from optical to Ethernet communication is a non-functional design simplification that does not alter image acquisition, processing, or diagnostic output. Removal of the Double Scan feature represents elimination of a user option rather than a functional compromise, and the control panel switch change is a materials substitution. All viewing software (EzDent-i K241114, Ez3D-i K231757) was previously cleared via separate 510(k)s and applied without modification.