INNOVISION-EXII

INNOVISION-EXII is a stationary X-ray system for obtaining diagnostic radiographic images of various anatomical parts in pediatric and adult patients in clinical settings. The device is not intended for mammography, angiography, interventional, or fluoroscopy use. It digitizes X-ray signals and converts them to DICOM format using Elui imaging software.

The subject device uses a CPI CMP 200 high-voltage generator (50kW or 80kW output) with 3-phase 400VAC ± 10% line voltage, compared to the predicate's various DRGEM generator models (32–82kW) with 220–480VAC options. Both use FDA-cleared digital flat-panel detectors, though the subject device is compatible with specific Vieworks VIVIX models while the predicate supports a broader range of detector types. Patient table movement ranges and detector stand dimensions differ between devices.

IEC 60601-1:3.2, IEC 60601-1-2:4.1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54, IEC 62304:2006, ISO 14971:2019, ISO 15223-1, NEMA PS3.1–3.20 (DICOM), 21 CFR 1020.30, and 21 CFR 1020.31.

Both devices perform the same function—producing diagnostic X-ray images using stationary radiographic methodology with digital detectors and DICOM output. Despite differences in generator models, line voltage options, and component configurations, these are design variations within the same product category. All detectors used in the subject device have prior 510(k) clearance, and risk analysis confirmed no adverse effect on safety or effectiveness. Clinical image evaluation demonstrated the subject device produces images with adequate contour, outline, contrast, and density suitable for diagnostic exams, equivalent to the predicate's performance.