uDR Aurora CX

The uDR Aurora CX is a digital medical X-ray imaging system that acquires two-dimensional X-ray images of the human body, including the skull, spine, chest, abdomen, extremities, and trunk. Qualified technicians use the device to capture diagnostic radiographic images for visualization by radiologists and clinicians; it is not intended for mammography.

The device shares the same product code (KPR), regulatory class (II), and regulation (21 CFR 892.1680) as its predicate. Key specifications are identical: 65kW/80kW power, 150kV maximum tube voltage, 1ms shortest exposure time, 0.6/1.2mm focal spot, and 12° anode target angle. Both use cesium iodide flat panel detectors and support DICOM3 standard output. The proposed device includes a built-in 2D camera for positioning (not in predicate), higher image matrix resolution (4267x4267 at 100μm vs. 3320x3408 at 125μm), and expanded detector travel range (≥90cm vs. ≥67cm).

ANSI/AAMI ES 60601-1:2005 & A1:2012 & A2:2021 (electrical safety), IEC 60601-1-2:2014+A1:2020 (EMC), IEC 60601-1-3:2008+A1:2013+A2:2021 (radiation protection), IEC 60601-2-54:2022 (X-ray equipment for radiography), IEC 60601-2-28:2017 (X-ray tube assemblies). ISO 10993-5 and ISO 10993-10 for biocompatibility of patient contact materials.

The uDR Aurora CX is substantially equivalent because it maintains identical core X-ray generation and imaging principles as the predicate (uDR 780i). All fundamental specifications—power, voltage, exposure time, focal spot, and detector scintillator material—are the same. The differences (higher resolution detectors, larger detector travel range, added 2D camera for positioning assistance) are improvements that do not alter the basic function or introduce new safety hazards; they enhance workflow efficiency without changing the method of X-ray image acquisition or clinical application. Clinical image evaluation by a board-certified radiologist confirmed diagnostic quality equivalent to the predicate.