FDA Radiology AI Devices

The TEX20 and TEX10 series Diagnostic Ultrasound Systems by Shenzhen Mindray are versatile, software-controlled ultrasound machines designed for imaging adults, pregnant women, pediatric patients, and neonates. They support multiple imaging modes such as B-mode, Doppler (including Color, Power, Pulsed Wave), 3D imaging, elastography, and contrast imaging, helping clinicians visualize and measure anatomical structures and blood flow across a wide range of body areas including ophthalmic, fetal, abdominal, cardiac, and musculoskeletal exams. These systems enhance diagnostic confidence and efficiency for healthcare providers through advanced imaging features and AI-assisted tools such as Smart Nerve, which assists in visualizing nerve plexuses for guidance.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system that wirelessly connects to smartphones or tablets to provide high-resolution, real-time diagnostic ultrasound images. It supports a wide range of clinical applications including cardiac, musculoskeletal, abdominal, fetal, and procedural guidance, helping healthcare professionals diagnose and monitor patients with ease and mobility.

The Philips EPIQ and Affiniti Diagnostic Ultrasound Systems are advanced ultrasound machines that provide diagnostic imaging and fluid flow analysis for various body regions. They help clinicians visualize internal organs and blood flow in real time, assisting in the diagnosis and treatment of conditions related to the abdomen, heart, brain, musculoskeletal system, and more. The system also includes liver fat quantification tools to measure attenuation and hepato-renal index, supporting assessment of liver health.

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.

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.

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 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.