FDA Radiology AI Devices

Kosmos is a handheld diagnostic ultrasound system combined with ECG and digital auscultation capabilities. It helps healthcare professionals perform clinical assessments across multiple body regions such as cardiac, thoracic, abdominal, vascular, and musculoskeletal areas by providing synchronized ultrasound images, ECG rhythms, and auscultation sounds. The device supports various ultrasound modes including B-mode, Doppler, and harmonic imaging, enhancing diagnostic capabilities in a single portable platform.

Us2.v1 is an AI-powered software platform that automatically processes and analyzes transthoracic cardiac ultrasound images to measure key cardiac structural and functional parameters. It helps cardiologists and healthcare providers by producing comprehensive reports to support clinical decision-making for adult patients.

The HS40 Diagnostic Ultrasound System by Samsung Medison is a versatile ultrasound imaging device designed to capture and display detailed ultrasound images using various modes such as 2D, Doppler, and 3D/4D imaging. It supports a wide range of clinical uses from obstetrics and gynecology to cardiac and musculoskeletal imaging, helping healthcare professionals diagnose conditions and analyze anatomical structures safely and effectively.

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.

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.

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.

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.

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.