FDA Radiology AI Devices

Ortho AI is a medical software device that helps orthopedic surgeons by using AI to semi-automatically measure lengths, angles, and implant positions on radiographic images. It assists in preoperative and intraoperative planning for hip, knee, and lumbar spine surgeries through digital annotations and measurements, improving surgical planning accuracy and efficiency.

The Yushan X-Ray Flat Panel Detector is a digital radiography detector that captures high-quality X-ray images of the human anatomy for general projection radiographic use. It helps healthcare professionals obtain clear images quickly and efficiently, suitable for many standard imaging applications except mammography, fluoroscopy, tomography, and angiography. The device supports wired and wireless operation and includes software for image processing and workflow management, facilitating smoother clinical integration and better patient care.

The OrthoNext Platform System is a web-based software that helps healthcare professionals plan orthopedic surgeries and treatments by overlaying product templates on X-ray images and providing measurement and simulation tools. It assists in both preoperative and postoperative planning, enabling clinicians to make informed decisions by digitally visualizing and measuring treatment options.

The TOPAZ Mobile X-ray System by DRGEM Corporation is a portable X-ray machine designed to obtain high-quality digital radiographic images for patients who cannot be moved to the radiology department. It features a motorized drive mechanism for easy mobility, a flat panel digital detector for rapid image acquisition, and enhanced software for image processing. The system supports various flat panel detectors and includes a touchscreen interface to facilitate workflow, helping clinicians quickly and accurately examine patients in bed or other immobile settings.

The DRX-Revolution Mobile X-ray System by Carestream Health is a portable digital X-ray system designed for bedside or mobile use, enabling radiographic examinations of various anatomical regions on pediatric and adult patients. It facilitates image acquisition and processing outside standard stationary X-ray rooms, helping clinicians to obtain high-quality diagnostic images conveniently and efficiently in different clinical settings.

The Digital Radiography System (ManntiX B, ManntiX K) by Shenzhen Browiner Tech Co., Ltd is a portable digital X-ray system designed to acquire high-quality X-ray images of various parts of the patient's anatomy including head, spine, chest, abdomen, pelvis, and extremities. It supports different digital detectors and image processing systems to assist clinicians in obtaining and viewing diagnostic images conveniently. It helps physicians and technicians capture diagnostic X-ray images efficiently in diverse clinical settings.

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.

Navbit Rapid Surgical Plan is a software tool designed to assist surgeons in planning primary total hip replacement surgeries. It analyzes X-ray images of a patient's hip and spine to provide recommendations on the placement of hip replacement components, aiming to reduce complications. The software helps surgeons by offering data-driven guidance based on patient-specific anatomy and mobility.

The Rextar Pro is a portable, handheld extraoral X-ray device designed for use by trained dentists and dental technicians to produce diagnostic X-ray images using intraoral image receptors. It is a battery-powered high-frequency X-ray generator with specialized shielding to minimize radiation exposure to users. This lightweight and compact device helps clinicians obtain high-quality dental images conveniently and safely.

The Nanox.ARC is a stationary, stand-alone digital tomosynthesis X-ray system designed to produce tomographic images of various body regions like musculoskeletal system, lungs, abdomen, and paranasal sinuses. It aids clinicians by providing 3D-like images synthesized from multiple low-dose X-ray images taken during a single sweep, helping reduce overlap of structures and improving diagnostic accuracy. The system is intended for use by trained radiologists and technologists in hospitals and imaging centers for adult patients.