FDA Radiology AI Devices

The 5000 Compact Series Ultrasound Systems by Philips Ultrasound LLC is a diagnostic ultrasound imaging system equipped with an AI-powered Auto Measure feature. It provides semi-automated, editable 2D and Doppler measurements primarily for adult echocardiography, helping clinicians obtain accurate cardiac measures efficiently. The system supports a wide range of clinical applications including cardiac, abdominal, vascular, obstetric, and musculoskeletal imaging, and is used in various clinical settings such as hospitals and clinics.

Koios DS is an artificial intelligence software tool that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules. It processes user-selected regions within the images to provide AI-derived risk assessments for cancer, and generates descriptors following established medical lexicons to improve diagnostic accuracy and reduce variability among physicians. The software also functions as an image viewer and supports image annotation and reporting, helping clinicians make more informed decisions in managing patients with suspicious lesions.

Fetal EchoScan is an AI-powered software tool that assists physicians in analyzing fetal heart ultrasound videos during the second trimester. It helps identify suspicious anatomical findings that may indicate fetal congenital heart defects, enhancing diagnostic accuracy and aiding clinical decision-making without replacing standard care.

The Resona A10S and related series are advanced diagnostic ultrasound systems used by healthcare professionals to acquire, display, and analyze ultrasound images and measurements of the human body. The system supports a wide range of ultrasound imaging modes and can be used in diverse clinical applications such as cardiac, abdominal, gynecologic, and musculoskeletal exams, thus aiding clinicians in diagnosis and patient care.

The Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) by Telefield Medical Imaging is a portable, software-controlled ultrasound system designed for real-time visualization of anatomical structures and blood flow using B-mode, color Doppler, and pulsed wave imaging. It aids healthcare professionals by providing detailed imaging and fluid flow analysis across multiple body regions such as abdominal, musculoskeletal, and vascular areas, facilitating diagnosis at the point of care.

The HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a versatile ultrasound imaging system used by healthcare professionals to obtain and analyze ultrasound images and body fluids. It offers multiple imaging modes including 2D, Color Doppler, Power Doppler, M mode, Pulsed and Continuous Wave Doppler, Tissue Doppler Imaging, and advanced AI-based features such as BiometryAssist, HeartAssist, ViewAssist, and others to aid in image recognition, measurement, and workflow efficiency. It is intended for clinical use in various applications including fetal, abdominal, cardiac, musculoskeletal, and more.

EchoMeasure by iCardio.ai is an AI-powered software that analyzes previously acquired cardiac ultrasound images to automatically measure key cardiac anatomical parameters. It assists cardiologists and healthcare professionals by providing accurate measurements for clinical decision-making, enhancing efficiency and supporting diagnostic review.

The SpineUs™ System by Verdure Imaging is a diagnostic ultrasound platform designed to help trained chiropractors and radiologists acquire, view, segment, and measure spinal ultrasound images. It uses AI technology to automatically segment vertebral bone structures and provides 3D reconstructions and quantitative measurements such as intervertebral angles and spine curvature, aiding clinical evaluation of the spine in both hospital and clinic settings.

The EPIQ Series Diagnostic Ultrasound System by Philips is an advanced ultrasound imaging device that uses AI-powered software to aid clinicians in semi-automated quantification of heart valve function, specifically assessing the tricuspid valve and mitral valve regurgitation. This helps improve accuracy and efficiency in diagnosing cardiac conditions by providing detailed measurements and flow analysis from 3D ultrasound images.

EchoSolv AS is a cloud-based AI and machine learning decision support software designed to help cardiologists assess severe aortic stenosis (AS) from transthoracic echocardiogram data and patient demographics. It provides a categorical probability of severe AS to assist in diagnosis alongside clinical guidelines, improving identification accuracy and supporting patient management decisions during echocardiogram interpretation.