Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))

The Digital Radiography X-ray System (SONTU100-RAD(E) and SONTU300-Mars(E)) is a stationary X-ray system used in hospitals, clinics, and medical practices for radiographic imaging of the whole body including skull, chest, abdomen, and extremities in adult and bariatric patients. It uses digital detectors to convert X-rays into diagnostic images and is not intended for mammographic applications.

The proposed device is substantially similar to predicate devices in intended use, materials, and biocompatibility. Minor differences include: different X-ray tube models (LQ 16, E7843X, E7252X variants with varying heat capacities and anode frequencies), simplified collimator configuration without Cu filter feedback, detector models (SONTU50 series) tested to be equivalent to predicate detectors, and reduced features in some configurations (e.g., no Touch User Interface module or Smart Remote Control) for cost reduction in lower-end market segments.

AAMI ES60601-1 (IEC 60601-1:2005 Edition 3.2 2020-08), IEC 60601-1-2:2020, IEC 60601-2-28:2017, IEC 60601-2-54:2022, IEC 60601-1-3:2021, IEC 60601-1-6:2020, IEC 60613:2010, IEC 60336:2020, ASTM D4169-2022, and ANSI IEEE USEMCSC C63.27-2021. Flat panel detector performance was tested for effect image area, dose range, dynamic range, spatial resolution, contrast resolution, uniformity, modulation transfer function, and detective quantum efficiency.

The proposed device maintains the same intended use, indications, product codes (KPR, MQB), and regulatory classification (Class II) as the predicates. Although component specifications differ (tube heat capacity, collimator features, detector models), all differences represent cost-reduction modifications or alternative component selections that do not introduce new safety risks. Non-clinical testing demonstrates the flat panel detectors are equivalent to predicate detectors in performance parameters, and concurrence evaluation on phantom and patient images (chest, spine, joints, skull, pelvis) confirms diagnostic image quality equivalent to cleared predicate devices. Risk analysis identified no negative safety or efficacy impacts from these differences.