FDA Radiology AI Devices

LumiNE US is a visualization software designed to help neurosurgeons and medical professionals prepare for surgery by converting 2D MRI and CT images into 3D models using AI-based segmentation. It enables visualization through augmented reality using head-mounted displays, assisting in understanding brain tumors and anatomy before surgery. The software is not intended for diagnostic use but to support surgical planning by providing enhanced image insights.

ADAS 3D is an AI-powered software tool that processes cardiac MRI and CT images to support visualization, quantification, and analysis of heart structures and myocardial fibrosis in patients with cardiovascular disease. It aids medical professionals in making informed decisions for cardiac care by providing detailed 3D imaging data, especially for pre-planning and during electrophysiology procedures.

uAI Portal is a medical imaging software system developed by Shanghai United Imaging Intelligence Co., Ltd. It provides tools to view, manipulate, and evaluate CT angiography studies focused on vascular structures within various anatomical regions including lower extremities, head and neck, coronary arteries, pulmonary arteries, and aorta. The software uses AI-based segmentation algorithms to help clinicians analyze vessel structures accurately and efficiently, making it easier to interpret complex vascular imaging data and facilitating clinical decision-making.

Imbio PHA (4.0.0) is a medical image processing software designed to measure the maximal diameters of the heart's right and left ventricles, the main pulmonary artery, and the ascending aorta from CT pulmonary angiography scans. It uses artificial intelligence to identify and measure these structures, providing annotated images and summary reports to assist clinicians in evaluating cardiovascular health.

HealthCCSng is a software tool that uses artificial intelligence to automatically detect and measure calcified plaques in the coronary arteries from routine non-gated, non-contrast CT scans. It provides an exact calcium score and categorizes the amount of calcium present, with results integrated into the radiologist's workflow to assist in assessing risk for coronary artery disease.

qCT LN Quant is a software tool that helps radiologists track, assess, and quantify lung nodules seen in CT scans. It provides volumetric and diameter measurements of user-selected nodules, with 2D and 3D visualizations, and uses AI algorithms to assist in characterizing nodules including measurements like volume doubling time and density. It supports clinical decision-making with integrated risk calculators based on established lung nodule malignancy and management guidelines.

The Precision AI Surgical Planning System (PAI-SPS) is a software and hardware system designed to assist surgeons in preoperative planning and intraoperative guidance for shoulder replacement surgeries. It creates a 3D model of the patient's shoulder joint from CT scans, allowing surgeons to visualize and plan implant placement precisely. Custom surgical guides are also produced to help accurately position shoulder implant components during surgery, enhancing surgical outcomes.

CardIQ Suite is a non-invasive software tool that analyses 2D and 3D CT cardiac images to assist clinicians in visualizing and measuring heart structures and vessels. It provides calcium scoring to evaluate calcified plaques and uses deep learning algorithms to automate segmentation and labeling of heart and coronary arteries, improving diagnostic workflow for cardiovascular diseases.

BriefCase-Triage is an AI-powered software designed to assist hospital networks and trained radiologists in identifying suspected pulmonary embolism cases from CT pulmonary angiography (CTPA) images. The software analyzes images in parallel with standard interpretation, flags potential positive findings, and notifies clinicians with compressed preview images for triage purposes, helping prioritize urgent cases and reduce turnaround times without replacing standard diagnostic workflows.

RUS by Hutom Inc. is a medical imaging software designed to aid healthcare professionals in reading, interpreting, and planning treatment based on iodine contrast-enhanced abdominal CT scans. The software provides basic imaging tools, 3D modeling, and segmentation of anatomical structures, including organs and vessels, enhancing surgical planning and diagnosis. It incorporates AI-based machine learning models to improve accuracy in organ segmentation, vessel detection, and pneumoperitoneum analysis, supporting clinicians in patient management decisions.