FDA Radiology AI Devices

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound machines designed to capture and display ultrasound imaging including B-mode, Doppler modes, 3D/4D imaging, and provide measurement and analysis tools to assist healthcare professionals in diagnosing various conditions. They support a wide range of clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more, helping clinicians in hospitals and clinics perform accurate diagnostic imaging and fluid analysis efficiently.

The Aplio a550, a450, and a Diagnostic Ultrasound Systems from Canon Medical Systems Corporation provide high-quality ultrasound images in various modes including 2D, Doppler, Color Doppler, Elastography, and 3D/4D imaging. These systems support advanced features enhanced by artificial intelligence and machine learning to assist clinicians in diagnostics across multiple clinical applications such as fetal, abdominal, cardiac, vascular, musculoskeletal, and more.

The Voluson P6 and Voluson P8 are general-purpose diagnostic ultrasound systems designed for use by trained healthcare professionals. These systems support a variety of clinical applications, including fetal/obstetrics, abdominal, cardiac, pediatric, vascular, musculoskeletal, and small organ imaging. They provide high-quality real-time imaging, including 3D/4D modes, and Doppler imaging types, aiding clinicians in the diagnosis and monitoring of patients in hospital or clinical settings.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 by Canon Medical Systems Corporation, is a high-quality diagnostic ultrasound system that provides detailed visualization of structures and dynamic processes in the human body. It supports multiple ultrasound modes and is suitable for use in hospitals and clinical settings, aiding clinicians in diagnosing conditions across areas including fetal, abdominal, cardiac, musculoskeletal, vascular, breast, and more.

The Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that automatically analyzes previously acquired cardiac ultrasound images to estimate the left ventricular ejection fraction. This helps clinicians assess heart function more efficiently and accurately by providing automated measurements, confidence metrics, and video clip visualizations within compatible ultrasound or PACS systems.

Follicle Clarity is a cloud-based AI software that helps clinicians by automatically detecting and measuring the number and size of ovarian follicles from transvaginal ultrasound images. It provides graphical and tabular summaries of these measurements to assist in fertility monitoring and related clinical decisions.

The Voluson S Series (including S6, S8, S8t, S10, and S10 Expert) by GE Healthcare is a general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It provides high-performance ultrasound imaging and analysis with a focus on real-time 3D/4D acquisition across multiple clinical applications such as obstetrics, abdominal, cardiac, vascular, and musculoskeletal imaging. The system supports a variety of probes and modes including Doppler imaging, elastography, and contrast imaging, helping clinicians visualize and measure various body tissues and fluids in a hospital or clinical setting.

TOMTEC-ARENA is medical software designed to help clinicians review and quantify cardiovascular, fetal, and abdominal ultrasound images. It incorporates AI to provide semi-automated measurements, improving workflow efficiency while allowing users to edit or accept these measurements. This supports physicians in diagnosing suspected diseases by providing detailed and accurate imaging analysis.

BU-CAD is a software application designed to assist physicians by analyzing breast ultrasound images to identify and evaluate soft tissue lesions suspicious for breast cancer. It highlights regions of interest and provides malignancy scores and BI-RADS classifications to support clinical decision-making. It also supports viewing of mammography images and includes tools for image adjustment and documentation, helping improve diagnostic accuracy and efficiency.

EchoGo Core (2.0) is an AI-powered software that analyzes ultrasound images of the heart (echocardiograms) to automatically quantify and report cardiac function metrics. It assists physicians by providing measurements like ejection fraction, ventricular volume, and strain, helping in cardiovascular diagnosis for adult patients.