Europa (Alternative: AiRTouch) portable X-ray system

The Europa (AiRTouch) portable X-ray system is a battery-powered diagnostic X-ray device intended for use by trained doctors to produce X-ray images of extremities in adult and pediatric patients over 12 years old. It generates X-rays with variable tube current (2–5 mA) and voltage (50–90 kVp) and is mounted on a tripod stand for stand-mounted use only.

The subject device enables manual user selection of power and exposure time, whereas the predicate device has fixed power settings. The Europa offers variable kVp (50–90 kV in 1 kV steps) and mA (2–5 mA in 1 mA steps), compared to the predicate's fixed 60 kVp and 2.0 mA. Differences also include battery capacity (2200 mAh vs. unspecified), focal spot sizes (0.5–0.8 mm vs. 1.2 mm), and physical dimensions and weight across four model variants.

Testing was performed per IEC 60601-1:2020, IEC 60601-1-2:2020, IEC 60601-1-3:2021, IEC 60601-2-28:2017, IEC 60601-2-54:2022, and IEC 62133:2012. The device also conforms to 21 CFR 1020.30 and 21 CFR 1020.31 for diagnostic X-ray systems and radiographic equipment performance standards.

Both devices are portable X-ray systems for diagnostic imaging of patient extremities using the same general-purpose diagnostic X-ray operating principle. Although the subject device offers variable power and exposure settings while the predicate uses fixed parameters, this enhancement does not change the fundamental intended use, technology class, or safety profile. Clinical images demonstrated appropriate image quality of anatomical structures, and performance testing confirmed the device meets applicable safety and performance standards equivalent to those of the predicate device.