FDA Radiology AI Devices

X Sensor is a digital intraoral dental x-ray sensor that captures x-ray photons and instantly converts them to digital images for dentists to view and analyze. It enhances dental diagnostic workflows by providing faster image acquisition with high resolution and image quality, making diagnosis more efficient and reliable.

The uDR 380i Pro from Shanghai United Imaging Healthcare Co.,Ltd. is a mobile digital radiography system that captures X-ray images of human anatomy for medical diagnosis. Designed for use on both adult and pediatric patients, it is especially useful for patients who cannot be moved to a traditional radiology room. The system includes flat panel detectors, a high-power generator, and a maneuverable design, enabling clinicians to obtain high-quality diagnostic images at the point of care.

Definium Pace Select ET is a digital radiography system designed to produce detailed X-ray images of multiple body parts including the skull, spine, chest, abdomen, and extremities for patients of all ages. It features advanced motorized components for positioning and enhances image acquisition with options like image pasting to stitch sequential images, improving workflow and diagnostic capabilities. The system is intended for routine radiography exams and helps clinicians by providing high-quality digital X-ray images that can be easily reviewed and shared.

The GM85 Digital Mobile X-ray Imaging System by Samsung Electronics is a mobile X-ray device designed to generate digital radiographic images of human anatomy. It uses advanced digital detectors and software for image processing and communication with hospital information systems, aiding clinicians in efficient and accurate imaging workflows.

Overjet Image Enhancement Assist is a software tool that improves the quality of dental x-ray images such as bitewing, periapical, and panoramic images. It uses AI algorithms to reduce noise and enhance contrast and sharpness, helping dental professionals see clearer images for better diagnosis. The software operates within the Overjet device platform and is intended to be an optional enhancement tool, not a replacement for existing imaging systems.

Velmeni for Dentists (V4D) is a computer-assisted detection software that helps dentists identify dental caries, restorations, fixed prostheses, and implants in various types of dental radiographs such as bitewing, periapical, and panoramic images. It uses machine learning algorithms to analyze radiographs and highlight areas of interest, providing additional information to aid clinical decisions without replacing dentist judgment.

The Overjet Charting Assist is a software system that helps dental professionals analyze 2D dental X-rays by detecting natural dental structures like tooth anatomy and numbering, as well as restorative dental work such as crowns and implants. It supports clinicians by automating dental chart creation from images, aiding in more precise and efficient dental assessments.

Rayvolve by AZmed SAS is an AI-powered software designed to assist radiologists and emergency physicians in detecting fractures from X-ray images of various musculoskeletal regions in adults and children aged 2 years and older. It enhances fracture diagnosis by automatically highlighting potential fractures on standard radiographic views, improving diagnostic accuracy and workflow efficiency.

SMART Bun-Yo-Matic X-Ray is a software tool that uses X-ray images of the foot and ankle to create 3D mathematical models, provide radiographic measurements, and assist orthopedic healthcare professionals in diagnosis and surgical planning. The software visualizes patient anatomy and orthopedic fixation devices, enabling precise pre-surgical planning to improve treatment outcomes for foot and ankle conditions such as hallux valgus.

VEA Align and spineEOS are cloud-based medical imaging software products by EOS imaging designed to assist healthcare professionals. VEA Align helps assess spinal and lower limb alignment using 2D X-rays with AI-generated anatomical landmarks for precise angle and length measurements. spineEOS facilitates preoperative planning for spine surgeries with access to 3D spine datasets and clinical measurements, enabling tailored surgical strategies. Both tools support clinicians by improving diagnostic accuracy and surgical planning through advanced image analysis and AI.