Dental Cone Beam Computed Tomography System

The Dental Cone Beam Computed Tomography System is an X-ray imaging device intended for use by medical institutions to diagnose conditions of the oral and maxillofacial regions. It uses cone beam CT technology to acquire cross-sectional images that are reconstructed into 3D anatomical structures, with adjustable field-of-view sizes and dose modes for both adult and pediatric patients.

The subject device uses a high-frequency, constant-potential generator with a stationary anode tungsten target operating at 80–100 kV (versus predicate's 120 kV peak) and tube currents of 2–12 mA. It features an amorphous silicon detector with 1536×1536 pixel matrix and 100 μm² pixel pitch (versus predicate's 1536×1920 and 127 μm²), and slightly higher anode capacity (49 kHU vs. 30 kHU). The gantry performs 360° rotation with vertical orientation, matching the predicate.

IEC 60601-1-2:2014+A1:2020; IEC 60601-2-63:2012+A1:2017+A2:2021; IEC TS 60601-4-2:2024; IEC 60601-1:2005+A1:2012+A2:2020; IEC 60601-1-3:2008+A1:2013+A2:2021; 21 CFR Part 1020.30, 1020.31, 1020.33; DIN 6868-161; ISO 10993-1.

The subject device operates on identical cone-beam X-ray principles with the same intended use (oral and maxillofacial CBCT diagnosis). Although the tube voltage, current ranges, detector size, and pixel matrix differ from the predicate, these differences do not affect safety or efficacy: lower voltage/current ranges remain within diagnostic capability, the smaller detector alters only scan field size, and 1536×1536 pixels provides sufficient image resolution. Performance testing (bench testing per FDA guidance and clinical image review by a certified radiologist) confirmed image quality and safety are equivalent to the predicate device.