FDA Radiology AI Devices

LOGIQ E10 is a general-purpose diagnostic ultrasound imaging system designed for use by qualified physicians. It supports multiple ultrasound modes such as B-mode, Doppler imaging, harmonic imaging, elastography, and 3D/4D imaging, providing digital image acquisition and processing. The system includes AI-powered features like Auto Renal Measure Assistant and Auto Abdominal Color Assistant to assist clinicians by automating measurements and suggesting anatomical views, thus improving workflow efficiency and diagnostic accuracy.

The ACUSON Sequoia, Sequoia Select, and Origin are advanced multi-purpose diagnostic ultrasound systems by Siemens, designed for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, and musculoskeletal imaging. They incorporate AI-based software applications (AI Measure, AI Assist, 2D HeartAI, 4D HeartAI) to assist clinicians in cardiac imaging by automating measurements, image annotation, and analysis, thereby improving workflow and diagnostic confidence.

The Voluson Expert series (including models 22, 20, and 18) is a general-purpose ultrasound system designed for use by trained medical professionals. It supports a wide range of clinical applications including obstetrics/gynecology, abdominal, cardiac, pediatric, musculoskeletal, vascular, and more. The system offers multiple imaging modes such as B-mode, Doppler modes, 3D/4D imaging, elastography, and advanced AI features like SonoPelvicFloor2.0, SonoAVC2.0, Fibroid Mapping, Blood Speckle Imaging, and Ophthalmic Artery Measurement. These AI features assist clinicians by automating tasks such as organ and lesion segmentation, improving workflow efficiency and diagnostic confidence. It is intended for use in hospitals or clinics and complies with medical device safety standards.

The Philips Lumify Diagnostic Ultrasound System is a portable ultrasound device used by healthcare professionals to capture high-resolution ultrasound images and perform fluid flow analysis in various clinical applications including cardiac imaging. It incorporates an AI-based Auto EF Quantification feature that automatically assesses cardiac function by measuring the left ventricle’s ejection fraction, improving clinical workflows during cardiac examinations.

The Ultrasound System 1300 by BK Medical ApS is a mobile ultrasound system designed for diagnostic imaging and fluid flow analysis across multiple clinical applications including fetal, abdominal, neuro, musculoskeletal, and vascular imaging. It aids clinicians by providing advanced imaging modes and AI software features like Prostate Volume Assist for workflow improvement and accurate prostate volume measurements.

Sonix Health is a software product that assists clinicians in analyzing adult echocardiography ultrasound images. It uses artificial intelligence to automatically classify ultrasound views, segment anatomy, and perform semi-automated measurements, helping physicians quantify cardiac function more efficiently. The software generates reports based on B-mode, M-mode, and Doppler ultrasound images and supports manual verification and adjustment of AI results.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound device that wirelessly connects to iOS or Android devices to provide real-time, high-resolution diagnostic ultrasound images across many clinical applications such as cardiac, abdominal, pediatric, and musculoskeletal imaging. It helps healthcare professionals by offering dual-array transducer functionality in a single device, enhancing convenience and efficiency during ultrasound exams.

The Samsung V8/H8, V7/H7, and V6/H6 Diagnostic Ultrasound Systems are advanced ultrasound machines designed to obtain and analyze ultrasound images and body fluids. They support a wide range of clinical applications such as fetal/obstetrics, abdominal, gynecology, cardiac, musculoskeletal, and vascular imaging. The systems offer multiple imaging modes including 2D, Doppler, ElastoScan, and 3D/4D modes, helping healthcare professionals diagnose patients more effectively. An AI-based feature called NerveTrack provides segmentation of nerves during ultrasound examinations, aiding in procedures involving nerve identification.

Sonio Detect is a software tool that uses machine learning to help healthcare professionals during fetal ultrasound exams by automatically detecting views, anatomical structures, and verifying the quality of images in real-time. This supports sonographers and fetal specialists to ensure comprehensive and high-quality ultrasound examinations for fetuses from 11 to 37 weeks gestational age.

UltraSight AI Guidance is a mobile AI-based application that helps non-expert medical professionals acquire high-quality cardiac ultrasound images by providing real-time guidance on how to position and manipulate the ultrasound probe for standard transthoracic echocardiography views. It enhances image acquisition quality and enables better diagnosis even by novice users.