Azurion R3.1

The Azurion R3.1 is an interventional fluoroscopic X-ray system that provides real-time image visualization of patient anatomy during diagnostic, interventional, and minimally invasive surgery procedures. It is used for vascular, non-vascular, cardiovascular, and neuro procedures, as well as cardiac imaging applications, and can be deployed in hybrid operating rooms.

The only change to the subject device is a design modification to the mattress accessory: addition of a hook-and-loop fastener (Velcro) solution between the mattress and the system-integrated patient table (AD7X) to prevent mattress slipping. This fastener is added to all existing mattresses (yellow, green, blue) and a new gray mattress is introduced. All other fundamental technological characteristics remain identical to the predicate device.

Compliance demonstrated with IEC 60601-2-43, IEC 60601-2-28, IEC 60601-1-2, IEC 62304, IEC 62366-1, ISO 14971, ISO 15223-1, ISO 20417, NEMA XR-27, IEC 61910-1, and 21 CFR 1020.30 and 1020.32, among others. Non-clinical verification and validation testing confirmed functional and safety requirements.

Substantial equivalence is established because the subject device has identical indications for use, the same fundamental technological characteristics, and the mattress modification does not raise new safety or effectiveness questions. Non-clinical testing demonstrates compliance with all applicable consensus standards and that the device meets acceptance criteria and is adequate for its intended use, making it as safe and effective as the predicate Azurion R3.1 (K251827).