FDA Radiology AI Devices

The Aplio i900, i800, and i700 Software V8.1 Diagnostic Ultrasound System by Canon Medical Systems is an advanced ultrasound imaging platform. It provides high-quality ultrasound images across a variety of clinical applications, including fetal, abdominal, cardiac, musculoskeletal, and more. The system includes advanced imaging modes such as Doppler and elastography, and new AI-based features like Left Atrial Appendage analysis to improve diagnostic accuracy and workflow efficiency.

The HM70 EVO Diagnostic Ultrasound System by Samsung Medison is a mobile, software-controlled ultrasound imaging device that captures detailed 2D, 3D, and Doppler ultrasound images across a variety of clinical applications such as obstetrics, cardiology, musculoskeletal, and dermatology. It includes advanced AI-powered features for tasks like nerve detection and uterus assistance to improve diagnostic accuracy, supporting clinicians in making informed patient care decisions.

The EPIQ Series Diagnostic Ultrasound System by Philips is a diagnostic ultrasound imaging device that provides detailed ultrasound images and fluid flow analysis to assist clinicians in diagnosing a wide range of medical conditions across multiple body regions. It supports advanced modes such as transesophageal cardiac imaging and works in different clinical environments including hospitals and clinics. The system integrates with Philips EchoNavigator to aid in cardiovascular interventions by providing live ultrasound and X-ray guidance, enhancing the precision of treatments.

The 6440 MyLabX90 by Esaote is an advanced multifunctional ultrasound scanner that supports real-time imaging and analysis during diagnostic ultrasound procedures. It integrates AI features like automated endocardial border detection for cardiac function assessment and lesion contouring for breast exams, helping clinicians improve diagnostic accuracy and efficiency across multiple body regions.

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.

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.

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound devices for diagnostic imaging and fluid analysis of the human body. They support numerous clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging. These systems incorporate various imaging modes such as 2D, 3D, Doppler, and elastography, and include AI-powered features like BiometryAssist and ViewAssist that help with anatomical measurements and view recognition, aiding clinicians in making accurate diagnoses.

The V8 and V7 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound machines designed for a wide range of clinical applications including fetal, abdominal, musculoskeletal, cardiac, and more. They use various ultrasound imaging modes and AI-based tools to assist healthcare professionals in acquiring and analyzing ultrasound images for improved diagnosis and workflow efficiency.