Adora DRFi (04550010)

The Adora DRFi is a ceiling-suspended diagnostic X-ray system with a flat panel detector for radiography and radioscopy of the whole body in adult and pediatric patients. It allows patients in various positions (supine, standing, sitting, wheelchair, stretcher) and performs radiographic and radioscopic examinations, but is not intended for mammography.

The Adora DRFi uses a Canon CXDI-RF Wireless B1 flat panel detector (43×42 cm, 160-micron pixels) with a CPI Indico IQ 80 kW generator capable of 40–125 kV fluoroscopy and 40–150 kV radiography. The predicate Siemens Multitom Rax uses a proprietary detector (43×42 cm, 148-micron pixels) with a Siemens Polydoros F80 generator. Both systems support radiography, fluoroscopy, cine, and 3D acquisition; the Adora offers up to 999 auto-positions while Siemens offers over 1000 predefined positions. The Adora table features optional 340° rotation and longitudinal/transverse movement; the Siemens table is fixed.

IEC 60601-1 (Edition 3.2, 2020), IEC 60601-1-2 (Edition 4.1, 2020), IEC 60601-1-3 (Edition 2.2, 2021), IEC 60601-1-6 (Edition 3.2, 2020), IEC 60601-2-54 (Edition 2.0, 2022), IEC 62304 (2015), IEC 62366-1 (2020), 21 CFR Part 1020, ISO 13485, ISO 14971, and FDA guidance on device software and cybersecurity.

Both systems are stationary universal diagnostic X-ray platforms using ceiling-suspended tubes and flat panel detectors synchronized for rotation around a patient center, with substantially identical intended uses and target populations. Though component designs differ (e.g., detector pixel size, generator specifications, table mobility), the clinical capabilities are comparable and both support the same examination procedures. The differences reflect design philosophy rather than functional divergence; the Adora prioritizes ergonomics and workflow while the predicate is more traditional. Minor specification variations do not raise new safety or effectiveness issues.