FDA Radiology AI Devices

The B-Scan device by ACCUTOME, INC. is an ultrasound imaging system that uses pulsed echo technology to capture images inside the body. It assists clinicians by providing detailed images useful for diagnosis and treatment planning in radiology.

This product consists of ultrasonic probes used in diagnostic imaging. These probes emit and receive ultrasound waves to create images of the body's internal structures, helping clinicians visualize and assess patients non-invasively.

The Sonosite LX Ultrasound System by FUJIFILM Sonosite is an advanced ultrasound imaging device used in medical settings. It assists clinicians by providing high-quality ultrasound and Doppler images, facilitating diagnosis and patient care in radiology.

Vivid Pioneer is an ultrasound imaging system using pulsed Doppler technology to help clinicians visualize and assess blood flow and cardiac function. It supports medical imaging and diagnosis, assisting healthcare professionals in evaluating patient health.

The Mendaera Guidance System is an ultrasonic diagnostic transducer designed to assist clinicians in medical imaging procedures by providing real-time ultrasound images. It helps healthcare providers visualize internal structures, aiding in diagnosis and treatment guidance.

EchoGo Heart Failure 2.0 is an AI-powered software tool that analyzes echocardiogram images of the heart's apical four-chamber view to support clinicians in detecting heart failure with preserved ejection fraction (HFpEF). It provides a diagnostic aid by outputting a classification and a confidence score, enhancing cardiovascular assessments and helping guide clinical decision-making.

PIUR tUS Infinity is a computer-aided detection system that assists medical professionals by analyzing ultrasound images of the thyroid and thyroid nodules. It uses AI and machine learning algorithms to create 3D volume reconstructions from 2D ultrasound images, allowing quantification and visualization of thyroid nodules to aid diagnosis. The system integrates seamlessly with FDA-cleared ultrasound equipment and produces reports to support clinical decisions.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 by Canon Medical Systems Corporation is a high-quality ultrasound imaging device designed for use in diverse clinical applications, such as cardiac, abdominal, musculoskeletal, fetal, and small organs imaging. It provides advanced imaging modes including Doppler, Harmonic Imaging, Elastography, and AI-based improvements like Auto Plane Detection and Quick Strain to enhance workflow efficiency and diagnostic accuracy for clinicians.

FETOLY-HEART is a software tool that helps healthcare professionals during fetal ultrasound exams by automatically detecting key fetal heart views and assessing the quality of those views in real-time. It supports clinicians in ensuring a complete and accurate fetal heart examination, particularly in the second and third trimesters of pregnancy, improving diagnostic confidence and workflow efficiency.

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is an AI-powered software that assists medical professionals in analyzing thyroid ultrasound images by automatically localizing thyroid nodules and characterizing them using standardized descriptors based on ACR TI-RADS. It helps clinicians generate structured reports and improves accuracy in detection and classification of nodules, thereby supporting clinical decision-making in thyroid nodule management.