FDA Radiology AI Devices

The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems specialized for cardiac imaging but also capable of vascular and general radiology applications. Featuring AI-driven tools for cardiac image analysis, these systems enable clinicians to perform automated measurements and enhanced visualization to improve efficiency and reduce variability. They support various clinical settings including hospitals and private offices with a range of imaging modes and transducers.

The Caption Interpretation Automated Ejection Fraction Software uses AI to analyze transthoracic cardiac ultrasound images and automatically estimate the left ventricular ejection fraction. This helps clinicians in cardiac evaluations by providing a consistent and efficient measurement of heart function, aiding diagnosis and treatment decisions.

HealthMammo is an AI-enabled software tool designed to analyze 2D full-field digital mammograms to identify and flag suspicious findings. It assists radiologists by prioritizing mammogram cases in the PACS/worklist, helping clinicians review critical cases faster and improve workflow efficiency without replacing diagnostic evaluation.

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.