PROMO

The PROMO is a mobile x-ray system intended for obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis. It features a manually driven platform with a high-quality x-ray tube assembly, collimator, high voltage generator, digital flat panel detector, and touch screen LCD control console for user-friendly operation.

The PROMO is based on the predicate TOPAZ with the same x-ray detectors and exposure characteristics (40 kW output, 10-500 mA range, 40-125 kV range, 0.1-500 mAs range). Key differences include manual drive versus electrical motor drive on the predicate, a fixed column rotation (0°) versus ±325° on predicate, and an extended tube axis rotation range (-49° to +147° versus -30° to +90°). The device uses LUC-12L x-ray tubes with 0.6/1.5 mm focal spots and 14° target angle.

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, ISO 14971, IEC 62304, IEC 62366-1, NEMA PS 3.1-3.20, IEC 61910-1, and IEC TS 60601-4-2. FDA guidance documents on solid state x-ray imaging devices, substantial equivalence, device software functions, and cybersecurity were also referenced.

PROMO is substantially equivalent because it shares the same x-ray exposure characteristics, flat-panel detectors, and system control with predicate TOPAZ, with no negative impact on safety or effectiveness from design modifications. Bench testing demonstrated PROMO meets or exceeds TOPAZ in key image quality metrics including uniformity, signal-to-noise ratio, linearity, spatial resolution, and low contrast resolution. All differences (manual versus motor drive, adjusted rotation ranges, different x-ray tube models) were verified according to international safety and EMC standards with no adverse impact on safety or performance.