FDA Radiology AI Devices

The MasteRad MiniX Mobile Digital Imaging System (Mini-X) is a portable fluoroscopic X-ray system designed for real-time imaging and guidance during diagnostic radiography and surgical procedures of the extremities. Its mobility and advanced imaging technology facilitate easy positioning and high-quality visualization to assist medical professionals in various clinical settings, except neonates and mammography.

The MC2 Portable X-ray System by Oxos Medical is a handheld, portable X-ray device intended to help clinicians perform point-of-care imaging of joint and bone areas (extremities) outside of surgery. It uses advanced technologies including infrared tracking and LIDAR to position and ensure safe operation, producing high-quality images in single radiography, serial radiography, and fluoroscopic modes. The device connects wirelessly to tablets or monitors for image review and facilitates efficient orthopedic imaging in various clinical settings.

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.