FDA Radiology AI Devices

Preview Shoulder is a pre-operative planning software that helps orthopedic surgeons develop shoulder surgery plans by processing patient CT scans. The software reconstructs 3D models of the shoulder anatomy, allowing surgeons to digitally place implants and generate detailed surgical planning reports, thus aiding surgical preparation without providing diagnostic decisions.

Automatic Anatomy Recognition (AAR) is a software medical device that uses deep learning to automatically identify and contour anatomical structures from CT scans. It is designed to assist technicians and physicians in radiation therapy planning by providing precise contours of organs at risk in the head, neck, and chest areas. This helps improve the accuracy and efficiency of treatment planning for patients undergoing radiation therapy for cancers in these body regions.

AI Segmentation by Varian Medical Systems is a cloud-based AI software tool that segments patient anatomical structures from CT scans to assist radiation therapy treatment planning. It automatically delineates organs at risk in regions such as head and neck, thorax, pelvis, and abdomen, helping radiation therapy professionals by streamlining contouring tasks and integrating with treatment planning systems, though clinicians review and approve the results.

Saige-Q is a software tool that analyzes digital breast mammograms using artificial intelligence to identify exams that may contain suspicious findings suggestive of breast cancer. It helps radiologists prioritize these exams in their worklist, enabling faster review of potentially concerning cases. The tool provides passive notification codes but does not provide diagnostic decisions and supports both full-field digital mammography and digital breast tomosynthesis images.

BriefCase for RibFx is an AI-powered software that assists medical specialists by analyzing chest CT scans to identify and flag cases with three or more acute rib fractures. It provides notifications and low-quality preview images on a desktop application, helping radiologists prioritize and review urgent cases sooner, thereby improving workflow efficiency and patient care.

GI Genius is an AI-powered software and hardware system that helps doctors detect precancerous lesions like polyps in the colon during colonoscopy procedures in real-time. It enhances standard white-light endoscopy video by highlighting suspected lesions with superimposed green boxes, improving detection rates and potentially reducing colorectal cancer risk.

Eclipse II with Smart Noise Cancellation is software that improves digital X-ray images by reducing noise using advanced AI technology. It enhances images acquired with digital radiography systems, helping radiologists see clearer images for better diagnosis of adult and pediatric patients, excluding mammography.

DV.Target is a software product that uses machine learning algorithms to automatically delineate organs-at-risk on CT images. It supports radiation therapy planning by generating organ contours that clinicians can review and edit in a treatment planning system. The software operates on a server and integrates with clinical workflows through DICOM image routing.

The SIS System (Version 5.1.0) is a medical imaging software that helps surgeons, neurologists, and radiologists visualize specific brain structures such as the subthalamic nuclei and globus pallidus from MRI and CT scans. It uses advanced deep learning models to create 3D anatomical models to aid in stereotactic surgical planning and lead placement, improving visualization and accuracy during procedures.

The MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, and MAGNETOM Altea are magnetic resonance imaging systems designed to produce detailed cross-sectional images and spectra of the head, body, and extremities. These systems aid clinicians in diagnosis by providing high-quality images and offer specialized features such as interventional imaging support and automated workflows, improving reproducibility and efficiency.