INNOVISION-DXII

The INNOVISION-DXII is a stationary X-ray system that generates radiographic images of various anatomical parts of the human body for both pediatric and adult patients in clinical environments. It consists of an X-ray tube, high voltage generator, ceiling/floor-mounted tube supports, patient table, detector stand, and control console. The system is not intended for mammography, angiography, interventional, or fluoroscopy applications.

The subject device operates on the same principle as the predicate (INNOVISION-EXII) for generating X-rays and clinical imaging. Key differences include: (1) Android-based GUI software for the X-ray control console versus the predicate's console; (2) different high voltage generator specifications based on system requirements; (3) different X-ray tube models (RAD-14, E7239X, E7884X) from the predicate; (4) different collimator models; and (5) use of FDA-cleared X-ray detectors, some models differing from the predicate's detectors.

Performance testing was conducted according to IEC 60601-1-3, IEC 60601-2-28, and IEC 60601-2-54. Bench testing evaluated X-ray tube, collimator, and high voltage generator performance including voltage accuracy, X-ray tube current, radiation output reproducibility, linearity, half-value layer, loading time accuracy, and detector system functionality.

The device is substantially equivalent because it uses the same operation principle for X-ray generation and clinical imaging as the predicate device. Although several components (control console software, high voltage generator specifications, X-ray tube models, collimators, and some detectors) differ from the predicate, these differences were verified through FDA-recognized standards testing to show no new safety or effectiveness concerns. The bench test results demonstrated the device maintains safe and essential performance effectiveness equivalent to the predicate.