FDA Radiology AI Devices

Versana Premier is a general purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It supports multiple clinical applications such as fetal, abdominal, gynecological, cardiac, vascular, musculoskeletal, and more. It includes various advanced imaging modes and features AI-based enhancements like Whizz Label to assist clinicians in acquiring and interpreting ultrasound images efficiently and accurately. The system is intended for hospitals and medical clinics to aid in the diagnosis and assessment of medical conditions.

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound imaging devices used across multiple clinical applications including fetal, abdominal, cardiac, and musculoskeletal imaging. They incorporate AI-powered features such as HeartAssist and BiometryAssist to improve efficiency and accuracy by automatically identifying scanning views and aiding biometric measurements. These devices assist clinicians by providing comprehensive ultrasound imaging modes and enhancing workflow in hospitals and clinics.

AmCAD-UT is a Windows-based AI-assisted software designed to help clinicians analyze thyroid ultrasound images. After initial review by a physician, the software quantifies and visualizes sonographic features of thyroid nodules, specifically those larger than 1cm, aiding in clinical decision-making for biopsy recommendations. It facilitates detailed image analysis and generates automated reports to support thyroid cancer diagnosis and management.

The V8 Diagnostic Ultrasound System by Samsung Medison is a general-purpose, mobile ultrasound device that captures real-time images and analyzes body fluids across various clinical applications including obstetrics, cardiac, abdominal, and musculoskeletal imaging. It uses multiple imaging modes and some AI-based software features to assist clinicians in diagnosis and measurement, helping improve accuracy and efficiency in medical imaging.

The Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems are advanced ultrasound imaging devices used to capture diagnostic ultrasound images and analyze fluid flow in various parts of the human body. These systems include an AI-powered Auto Measure feature that semi-automates 2D and Doppler measurements during echocardiography, helping clinicians perform more efficient and standardized assessments with editable, semi-automated results.

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.