FDA Radiology AI Devices

The uAngio AVIVA CX is an advanced angiographic X-ray system designed to assist clinicians during diagnostic, interventional, and surgical procedures such as cardiac and neuro-angiography. It provides precise, intelligent image guidance with 2D and 3D imaging capabilities and software features such as camera-assisted recognition and voice control, helping to improve procedural accuracy and patient safety.

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.

EndoNaut is a software system designed to aid physicians during fluoroscopy X-ray guided procedures by overlaying preoperative 3D vascular anatomy onto live fluoroscopy images. It assists in accurately positioning surgical tools and endovascular devices in the chest, abdomen, pelvis, neck, and lower limbs for treatments like aneurysm repair and arterial embolization. This image fusion and navigation tool enhances procedural accuracy, although it does not replace the surgeon's judgment and requires real-time imaging confirmation before device deployment.

EndoNaut is a medical imaging software system that helps doctors during endovascular procedures by overlaying three-dimensional vessel images from preoperative scans onto real-time two-dimensional fluoroscopy images. This assists clinicians in accurately positioning catheters, guidewires, and stents within blood vessels in areas like the thorax, abdomen, pelvis, and lower limbs, improving procedural outcomes and patient care.

Cydar EV is a cloud-based software that enhances live X-ray fluoroscopy images by overlaying 3D vessel anatomy from preoperative CT scans. This helps clinicians during endovascular procedures by improving guidance for positioning devices like guidewires and catheters, especially in the abdomen, pelvis, and lower thorax.