BONX805

The BONX805 is a portable battery-powered X-ray system designed for diagnostic imaging of body extremities in adults and pediatric patients. It integrates an X-ray generator with embedded firmware control and is intended for use by qualified physicians or technicians in hospitals, clinics, and mobile settings. The device requires a separate external X-ray detector (digital or film type) to form a complete diagnostic system.

The BONX805 generates X-rays with tube potential of 50–80 kV (1 kV steps), fixed tube current of 2–5 mA, and exposure times from 0.03–2.00 seconds. It is powered by a 22.2 V lithium-ion polymer battery (1450 mAh). The predicate device (Remex KA6) operates at 40–70 kV with variable current (2–6 mA) and exposure times of 0.06–2.0 seconds. Both use battery power and MCU-controlled semiconductor switching for irradiation control.

IEC 60601-1:2005/AMD2:2020, IEC 60601-1-3:2008/AMD2:2021, IEC 60601-1-6:2010, IEC 60601-2-28:2017 (X-ray tube), IEC 60601-2-54:2009/AMD2:2018, EN 60601-1-2:2015+A1:2021, ISO 14971 (risk management), and relevant bench testing protocols for image quality and radiation safety.

Both devices share the same intended use (extremity radiography for adult and pediatric populations), identical indications, and comparable operational principles using battery-powered X-ray generation with MCU control. Although the BONX805 has narrower operating ranges (50–80 kV vs. 40–70 kV, fixed vs. variable current), bench testing demonstrated equivalent diagnostic performance: DQE measurements matched within ±3% uncertainty, spatial resolution was equivalent, and MTF differences were below 1%. The BONX805's lower power parameters raise no new safety or effectiveness issues, and radiation output complies with applicable safety limits identical to the predicate.