FDA Radiology AI Devices

MEDO-Thyroid is a cloud-based software that uses machine learning to help radiologists evaluate ultrasound images of the thyroid. It assists in measuring thyroid lobes and nodules, supports diagnosis by providing volume measurements and TI-RADS classification, and generates reports, improving the efficiency and accuracy of thyroid image assessment for adult patients.

The LVivo Software Application is an AI-powered tool that automates the analysis of ultrasound images, specifically echocardiograms, to measure cardiac functions such as left and right ventricular function and bladder volume. It helps clinicians accurately and efficiently assess heart structure and function in patients, supporting better diagnosis and management of heart conditions.

The Imagio Breast Imaging System is a diagnostic tool that combines optoacoustic imaging and ultrasound to provide detailed structural and functional information about breast abnormalities. It uses AI-based software to help healthcare providers better classify breast masses, thereby improving diagnosis. The device is designed to assist, not replace, mammographic screening or biopsy.

EchoGo Pro is an AI-powered software tool designed to assist physicians in diagnosing coronary artery disease by analyzing stress echocardiography ultrasound images. It processes images acquired during stress echo exams, automatically segments the left ventricle, and uses machine learning to provide a categorical assessment of the likelihood of significant CAD, helping clinicians make more accurate and consistent diagnoses.

LVivo Seamless is an AI software application that automatically analyzes echocardiogram ultrasound images to assess cardiac function by calculating parameters like ejection fraction (EF). It helps clinicians by streamlining the evaluation process, sending analyzed results directly to PACS for review, enhancing diagnostic efficiency and accuracy for patients with suspected cardiac disease.

EchoPAC Software Only / EchoPAC Plug-in is a diagnostic ultrasound image analysis software by GE that enables physicians to view, post-process, measure, and analyze ultrasound images across many clinical applications including cardiac, fetal, abdominal, musculoskeletal, and vascular imaging. It incorporates AI-based features to semi-automate cardiac measurements and streamline image interpretation, helping clinicians obtain quantitative data more efficiently and accurately.

Caption Guidance is an AI-powered software accessory designed to assist medical professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance to help users obtain standard echocardiographic views, improving image quality and diagnostic accuracy.

AVA (Augmented Vascular Analysis) by See-Mode Technologies is a software that uses artificial intelligence to analyze vascular ultrasound images from carotid and lower limb arteries. It segments vessel walls, measures carotid intima-media thickness, reads Doppler velocities, and generates detailed vascular ultrasound reports to aid clinicians like physicians and medical technicians in assessing cardiovascular health. The software runs on standard computers or cloud platforms and supports quality control by qualified clinicians to ensure accuracy.

The Vivid T8 and Vivid T9 are advanced ultrasound imaging systems designed primarily for cardiac imaging but also applicable to vascular and general radiology. These systems provide high-quality ultrasound imaging with various transducer options and include AI-based features that assist clinicians by semi-automating measurements and recognizing Doppler spectra. They support multiple clinical applications in hospital and private settings and enhance diagnostic accuracy and efficiency through AI integration.

The Vivid iq is a high-performance compact diagnostic ultrasound system made by GE Medical Systems Ultrasound. It supports a wide range of clinical applications including cardiovascular, abdominal, fetal, musculoskeletal, and more. The system enables automatic AI-based cardiac measurements and spectrum recognition to assist clinicians in analysis and diagnosis. It is intended for use by trained healthcare professionals in hospitals and private medical offices.