HnX-P1, HnX-PB

The HnX-P1 and HnX-PB are battery-powered portable X-ray systems designed for diagnostic imaging of body extremities. They consist of an LCD display, X-ray generator, tube assembly, collimator, and cart or stand. The devices are not intended for mammography or to replace stationary radiographic systems.

The proposed device is lighter (3.5 kg vs 7.5 kg) and more compact than the predicate. It uses a Li-Polymer rechargeable battery instead of lithium-ion, operates at 50–90 kVp (vs 40–90 kVp), generates 0.72 kW (vs 1.35 kW), and stores 10 technique memories via APR mode compared to 5 pushbutton memories in the predicate.

Laboratory testing followed IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54, IEC 62304, IEC 62366, ISO 14971, and ISO 15223-1. Cybersecurity and label requirements per CFR Part 801 were also addressed.

Both devices are portable X-ray systems with identical indications for use (diagnostic imaging of body extremities), same product code (IZL), same regulatory class (Class II), and same regulation (21 CFR 892.1720). The proposed device meets the same FDA performance standards and uses functionally similar core components (high-frequency generator, X-ray tube, collimator, soft-touch interface). Clinical image quality was confirmed through review of 30 image samples. Differences in weight, size, power output, and battery type do not adversely affect the intended use or safety profile.