uAngio AVIVA CX

The uAngio AVIVA CX is an angiographic X-ray system designed to provide image guidance in diagnostic, interventional, and surgical procedures. It can perform cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography, and whole body radiographic/fluoroscopic procedures across all human patient ages.

The proposed device matches the predicate (Azurion R2.1) in most specifications including 100 kW generator power, 1000 mA at 100 kV, 48 cm diagonal field of view, and identical image acquisition protocols. Minor differences include three focal spots (0.4, 0.6, 1.0 mm) versus two on the predicate, slightly improved pixel pitch (150 μm vs 154 μm), higher patient table weight capacity, and additional software features (uSpace camera-assisted recognition and uLingo voice control).

Compliance demonstrated with ANSI/AAMI ES60601-1:2005/A2:2021, ANSI/AAMI/IEC 60601-1-2:2014/A1:2021, IEC 60601-1-3:2021, IEC 60601-2-54:2022, IEC 60601-2-43:2022, IEC 60601-2-28:2017, and IEC 60825-1:2014. Non-clinical bench testing included Cone Beam CT performance, image registration fusion, DSA, 3D Roadmap, and software algorithm validation.

The device has identical classification, intended use, indications, and primary technical specifications as the predicate Azurion R2.1. Differences such as an additional focal spot, improved pixel pitch, and enhanced patient table capacity either improve performance or broaden applicability without introducing new safety or effectiveness concerns. Novel software features (uSpace and uLingo) are ancillary enhancements controlled by user triggering with hardware collision prevention, and comprehensive testing demonstrates these do not adversely affect safety or essential performance. Clinical image evaluation confirmed diagnostic quality across head, cardiac, body, and extremity procedures.