Allia Moveo

The Allia Moveo is an interventional fluoroscopic X-ray system designed for monoplane fluoroscopic and rotational imaging of human anatomy. It is indicated for cardiovascular, vascular, and non-vascular diagnostic and interventional procedures in patients from newborn to geriatric age, and can also be used with an operating room table for image-guided surgical procedures.

The Allia Moveo features a 41×41 cm square digital detector (compared to the predicate's 31×31 cm), a new C-arm mounted on a laser-guided motorized vehicle, a Performix Pulsar X-ray tube, a 100 kW Gaia high-frequency power unit, and an LFD collimator with spectral filtration and three integrated contour filter blades. It enables 3D acquisition with the gantry at the head, left, or right of the table, unlike the predicate which only allows head positioning.

IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-1-3:2008+A1:2013+A2:2021, IEC 60601-2-43:2022, IEC 60601-2-46:2023, and NEMA XR-27. The device complies with 21 CFR Subchapter J and was developed under GE HealthCare's quality system and design controls conforming to 21 CFR 820 and ISO 13485.

The Allia Moveo employs the same fundamental scientific technology, basic design, construction, materials, energy source, control mechanism, and operating principles as the predicate device K232344 (Allia IGS 7). Although the device introduces a new C-arm with modified detector mount and enhanced capabilities, these changes do not raise new questions of safety or effectiveness, and the indications for use remain identical to the predicate device.