Airbile-100

The Airbile-100 is a battery-powered mobile X-ray imaging device designed for hospital use to generate diagnostic radiographic images. It consists of an X-ray control unit, high-voltage generator, X-ray tube unit, and hand switch, and is intended for use by qualified doctors or technicians on both adult and pediatric subjects for imaging the skull, spine, chest, abdomen, extremities, and other body parts in various patient positions. The device does not include an X-ray detector; an external detector must be used with it.

The Airbile-100 is a line-operated portable device with a 5 kW high-frequency generator manufactured by POSKOM, achieving a peak voltage of 120 kV (versus 110 kV in the predicate), 100 mA current, and maximum exposure time of 0.1–100 mAs. Key differences include a wired hand-switch connection interface versus the predicate's Ethernet/Wi-Fi, and different collimator and software implementations, but all core electrical and performance parameters are identical or similar.

The device was tested to IEC 60601-1 (General Requirements), IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-2-28 (X-ray Tube Assemblies), and IEC 60601-2-54 (X-ray Equipment for Radiography and Radioscopy). Performance testing included imaging quality evaluation per IEC 62220-1-1, assessing Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE), Noise Power Spectrum (NPS), detector linearity, and spatial resolution.

The Airbile-100 is substantially equivalent to predicate device K182317 (AMADEO M-DR mini) because both share identical indications for use, product code (IZL), regulation number (21 CFR 892.1720), and 510(k) review panel classification. Key technical characteristics—generator type, output power, operating frequency, and tube current—are comparable and do not introduce new safety or effectiveness risks. Although the connection interface differs (wired hand switch versus Ethernet/Wi-Fi), the Airbile-100 operates as a stand-alone X-ray generator without network communication, making this difference immaterial to safety or effectiveness.