FDA Radiology AI Devices

The Vivid S60N and Vivid S70N are advanced general-purpose ultrasound imaging systems by GE Healthcare, specialized for cardiac imaging but also supporting a broad range of diagnostic ultrasound applications across the human body. These systems facilitate ultrasound imaging, measurement, display, and analysis to assist physicians in clinical environments such as hospitals and private offices, enhancing diagnostic accuracy and workflow efficiency through digital acquisition, processing, and semi-automated AI-based measurement features.

The Vantage Orian 1.5T with AiCE Reconstruction Processing Unit for MR is a 1.5 Tesla MRI system from Canon that enhances image quality by using AI-powered noise reduction techniques. This advanced software algorithm uses deep learning to reduce thermal noise and improve signal clarity, especially in brain and knee imaging, helping clinicians obtain clearer and more diagnostically useful MRI images.

Ezra Plexo Software is a medical imaging application designed to help radiologists view, manipulate, and compare 2D and 3D MR images through a web browser. It supports oncological workflows by enabling visualization, evaluation, quantification, and documentation of lesions, facilitating better clinical assessment and decision-making.

AI-Rad Companion Engine is a software platform that supports visualization and post-processing of medical images for diagnostic use, helping clinicians by facilitating measurement, analysis, and data management. It integrates with multiple imaging modalities and PACS systems, providing an interface to add additional AI-driven clinical processing extensions.

Rapid LVO is a software tool that helps hospitals and radiologists quickly identify and prioritize suspected cases of Large Vessel Occlusion (LVO) in head CT angiography images. It analyzes images using a software algorithm and provides notifications with preview images to assist clinical workflow, without replacing standard diagnostic procedures.

Deep Recon is an AI-powered image reconstruction software designed for CT scanners. It uses deep learning technology to produce clearer CT images with less noise and better low contrast detectability, helping clinicians get accurate diagnostic images while potentially reducing the radiation dose for patients. It supports scans of the head, chest, abdomen, cardiac, and vascular regions, and is integrated into specific United Imaging CT scanners.

InferRead Lung CT.AI is software that helps radiologists detect lung nodules in chest CT scans. It uses AI algorithms to identify and mark nodules, providing measurements and characterization to aid diagnosis, specifically targeting an asymptomatic population. The software integrates with existing PACS systems and assists clinicians by enhancing nodule detection sensitivity and reducing interpretation times.

Contour ProtégéAI is a software tool designed to assist medical professionals by automatically creating anatomical contours on CT and MR medical images using machine learning. It supports applications such as adaptive therapy, radiation treatment planning, and management of patient images. The software requires manual review and editing of contours to ensure accuracy, improving clinical workflow efficiency and patient care.

Rapid ASPECTS is an AI-powered software that helps doctors analyze CT brain scans to detect and score early signs of ischemic stroke by automatically segmenting brain regions and calculating an ASPECTS score. This aids clinicians in timely and accurate diagnosis, improving stroke assessment especially when expert radiologists are not immediately available.

CINA is an AI-based software that assists radiologists by analyzing head CT scans and CT angiographies to flag suspected cases of intracranial hemorrhage and large vessel occlusion. It provides timely notifications with preview images to help prioritize cases for quicker evaluation, improving workflow and patient care without altering original images or making direct diagnoses.