FDA Radiology AI Devices

ARTAssistant is software designed to process radiological images for use in radiation therapy. It helps clinicians analyze imaging data to assist in planning and delivering targeted radiation treatment to patients, improving the accuracy and effectiveness of therapy.

Overjet CBCT Assist is an AI-powered software designed to help radiologists process and analyze Cone Beam CT images more effectively. It aids clinicians by automating image interpretation tasks, improving diagnostic accuracy and efficiency in dental and maxillofacial imaging.

This product is a digital color Doppler ultrasound system that provides real-time imaging and blood flow visualization using pulsed Doppler ultrasound technology. It assists clinicians by allowing detailed examination of blood vessels and tissues, supporting diagnosis and treatment planning in various medical fields.

The ASUS Ultrasound Imaging System (LU800 series) is a medical device that uses pulsed Doppler ultrasound technology to produce detailed images for clinical diagnosis. It assists healthcare providers in visualizing internal body structures, enhancing diagnostic accuracy and patient care.

AVIEW Lung Nodule CAD is an AI-based software that assists radiologists by automatically detecting lung nodules in CT scans, helping to identify potential abnormalities early for better patient care.

The Hepatus and Fibrous series are diagnostic ultrasound systems designed to assist clinicians in imaging various anatomical structures using pulsed Doppler ultrasound technology. These systems help medical professionals by providing real-time visual information useful for diagnosis and patient management.

The Cartesion Prime (PCD-1000A/3) V10.21 is a computed emission tomography system developed by Canon Medical Systems Corporation. It is designed to produce detailed images of the body to help clinicians diagnose and evaluate various medical conditions through emission tomography techniques.

CT VScore+ is a software tool that helps clinicians evaluate calcified lesions in coronary arteries from non-contrast cardiac CT scans. It automatically calculates calcium scores, highlights calcium deposits on the images, and provides visualization aids to support cardiovascular risk assessment for patients aged 30 and older. The software uses deep learning to segment coronary arteries and quantify calcium, allowing for semi-automated, accurate, and reproducible results to improve clinical interpretation.

The Dendrite Imaging System is a handheld device used during surgery to capture and display autofluorescent images of nerves in real time. It helps surgeons locate nerve tissue by illuminating tissue with near ultraviolet light, which causes nerves to fluoresce naturally. The images are captured by a camera and displayed on a touchscreen, assisting surgeons to better identify and preserve nerves during procedures without replacing visual assessment.

The uDR Arria & uDR Aris are stationary digital X-ray imaging systems designed to acquire high-quality 2D X-ray images of various body parts to support radiologists and clinicians in diagnosing medical conditions. They include AI-assisted features like uVision for patient positioning and uAid for image quality assessment, helping improve clinical workflow and image quality control.