AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)

The AirRay-mini is a handheld, portable, battery-powered X-ray generator intended for use by qualified healthcare professionals to produce diagnostic X-ray images of extremities in adult patients. The device does not include an image receptor; diagnostic image quality depends entirely on separately paired solid-state detectors or digital radiography systems.

The AirRay-mini features an inverter-based generator with peak voltage of 80–90 kV, tube current of 5–10 mA, maximum power output of 500 W, weight of 3.5 kg, and total filtration of 2.5 mm aluminum. It operates on AC line power (100–240 V) or DC battery (22.2–25.2 V) and complies with IEC 60601 electrical safety and electromagnetic compatibility standards.

IEC 60601-1 (basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-28 (X-ray tube assemblies), and IEC 60601-2-54 (X-ray equipment for radiography and radioscopy). Software validation followed FDA guidance on premarket submissions for device software functions.

The AirRay-mini is substantially equivalent to the predicate device ADX6000 because both are portable X-ray generators with identical indications for use (diagnostic extremity imaging), product code (IZL), regulation number (21 CFR 892.1720), and comparable technological characteristics including generator type, peak voltage, tube current ranges, and power source. Design differences in form factor and mechanical configuration do not introduce new safety or effectiveness concerns and were confirmed through testing and risk management.