FDA Radiology AI Devices

Limbus Contour is a software tool designed to help medical professionals automatically create accurate contours of healthy anatomical structures from CT and MRI images. These contours are used to plan and evaluate radiation treatment for cancer patients, improving efficiency and consistency in treatment preparation.

The SpineUs™ System by Verdure Imaging is a diagnostic ultrasound platform designed to help trained chiropractors and radiologists acquire, view, segment, and measure spinal ultrasound images. It uses AI technology to automatically segment vertebral bone structures and provides 3D reconstructions and quantitative measurements such as intervertebral angles and spine curvature, aiding clinical evaluation of the spine in both hospital and clinic settings.

LVivo Software Application is an AI-powered software platform designed to automatically analyze ultrasound images of the heart and bladder. It calculates important functional and structural parameters of the heart's left and right ventricles and the bladder volume, helping clinicians with rapid and accurate assessments during routine echocardiographic exams and point-of-care settings.

MuscleView is an AI-powered software that automatically segments muscles and bones in MRI scans of the lower limbs. It calculates useful metrics such as muscle and bone volume, fat infiltration, and asymmetry to assist physicians in analyzing musculoskeletal health. The segmentations need to be reviewed and edited by trained clinicians. This tool helps improve the efficiency and accuracy of muscle and bone analysis from MRI images but is not intended for diagnostic use of diseases.

The CAC (gated) Algorithm is a software medical device designed to automatically detect and quantify coronary artery calcium from non-contrast ECG-gated cardiac CT scans. It aids physicians by providing calcium segmentation and quantification information integrated into their workflow, helping assess coronary artery health.

Constellation (CON-001) is an automated software tool that processes whole-body MRI images to segment anatomical regions and quantify various tissues such as muscles, fat, and organs. It provides clinicians with detailed quantitative reports with visual overlays to support clinical decisions without making autonomous diagnoses, focusing on healthy adult patients.

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.

Velacur is a portable ultrasound elastography device designed to assist clinicians in the assessment of liver diseases. It non-invasively measures liver tissue stiffness and fat content by analyzing shear wave speed and ultrasound attenuation, helping in the management of conditions such as hepatic steatosis. The device incorporates AI algorithms to improve image quality and accuracy of liver tissue characterization.