FDA Radiology AI Devices

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound imaging devices used to visualize and analyze structures within the human body. They support diverse clinical applications including obstetrics, cardiology, abdominal imaging, and musculoskeletal imaging through multiple ultrasound modes such as 2D, Doppler, and 3D/4D. The systems incorporate AI technologies to assist clinicians in fetal biometry and cardiac view recognition, helping improve diagnostic accuracy and workflow efficiency.

1CMR Pro is a medical software tool that helps clinicians view and analyze cardiovascular MRI images. It automates analysis of heart structure, function, and blood flow, improving the accuracy and precision of cardiac assessments. This supports better diagnosis and monitoring of heart diseases.

TeraRecon Cardiac.Chambers.MR is a software tool designed to automatically segment the anatomical structures of cardiac chambers from contrast or non-contrast cardiac MR scans in adult patients. It helps clinicians by providing precise delineation of the left and right ventricular walls, facilitating faster and more accurate cardiac assessment.

JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.

The RemedyLogic AI MRI Lumbar Spine Reader is a software tool that automatically analyzes MRI images of the lumbar spine to identify and measure anatomical features. It helps radiologists and spine surgeons by providing quantitative measurements and image segmentations, which can improve the efficiency and accuracy of their analyses and reporting. Users review and adjust the software's outputs before finalizing diagnostic or treatment decisions.

Neurophet AQUA (V3.1) is an automated medical software that analyzes brain MR images to help doctors by labeling, visualizing, and measuring brain structures and lesions. It compares these measurements to reference data, enabling clinicians to assess brain changes or abnormalities more efficiently and accurately.

TumorSight Viz is a cloud-based AI software that helps clinicians visualize and analyze breast MRI images in patients with early-stage or locally advanced breast cancer. It processes dynamic contrast-enhanced MRI data to provide 3D renderings, measurements, and segmentations of tumors, supporting more informed clinical evaluations and treatment planning.

Contour+ (MVision AI Segmentation) is a software tool that uses machine learning algorithms to automatically create contour outlines of anatomical regions on CT and MRI scans. It assists clinicians in radiation therapy planning by providing initial segmentations of organs and tissues, which professionals can review and modify before treatment planning. This speeds up the workflow and improves efficiency in radiation treatment preparation.

JLK-CTP is an image processing software that helps trained medical professionals analyze brain CT perfusion images. It automatically receives, processes, and visualizes dynamic CT perfusion datasets to calculate blood flow and volume parameters, aiding in the assessment of cerebral blood flow and tissue status in brain imaging.

cvi42 Software Application is a medical imaging software developed by Circle Cardiovascular Imaging Inc. that supports clinicians by enabling viewing, post-processing, and quantitative analysis of cardiovascular magnetic resonance (MR) and computed tomography (CT) images. It uses semi-automated machine learning algorithms to assist in measuring cardiac function, vessel characteristics, and calcified plaques, helping medical professionals in diagnostic decision-making related to heart and adjacent vessels.