FDA Radiology AI Devices

3DXR is a post-processing software application by GE Healthcare designed to perform three-dimensional reconstruction of images obtained through 3D acquisition modes of X-ray interventional systems. It incorporates a new Deep-Learning option, CleaRecon DL, to reduce streak artifacts in images, enhancing image clarity to assist physicians in diagnosis, surgical planning, interventional procedures, and treatment follow-up.

The ARTIS icono (VE40A) family and ARTIS pheno (VE40A) are advanced angiography systems that enable detailed imaging for diagnostic and interventional procedures. They support single-plane and biplane imaging with a motorized C-arm and flat panel detector, allowing clinicians to perform cardiac, neuro, general angiography, and image-guided surgeries. The systems provide 2D and 3D imaging capabilities, including 3D reconstruction software (DynaCT), which helps clinicians visualize both hard and soft tissues for diagnosis, surgical planning, and treatment follow-up.

The O-arm O2 Imaging System by Medtronic Navigation, Inc is a mobile X-ray device designed to provide detailed 2D and 3D imaging of patients' bony anatomy and metallic objects, mainly used during image-guided surgeries. It includes advanced software features such as metal artifact reduction and dose reduction using machine learning, helping clinicians obtain clearer images with lower radiation exposure for improved surgical navigation and patient safety.