FDA Radiology AI Devices

The TE Air Diagnostic Ultrasound System is a portable, general-purpose ultrasound device that uses wireless-connected probes and a mobile app to capture and display ultrasound images and Doppler flow information. It is intended for use by trained healthcare professionals to perform real-time ultrasound imaging, measurement, and analysis across a variety of anatomical regions and clinical applications, including fetal, abdominal, cardiac, musculoskeletal, thoracic, vascular, and urology exams. The system supports multiple imaging modes such as B-mode, M-mode, color and power Doppler, and tissue harmonic imaging, facilitating detailed internal body visualization and aiding diagnosis in clinics and hospitals.

The Diagnostic Ultrasound System MX6 series by Shenzhen Mindray Bio-medical Electronics Co., LTD is a general-purpose, software-controlled ultrasound imaging device for a wide range of clinical applications including adult, pediatric, and neonatal exams. It supports various ultrasound modes such as B-mode, Doppler, Color Doppler, 3D/4D imaging, elastography, and contrast imaging. This device aids healthcare professionals in capturing, measuring, and analyzing ultrasound images to support medical diagnosis across multiple body regions such as abdomen, obstetrics, gynecology, cardiac, and musculoskeletal systems.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 by Canon Medical Systems is a diagnostic ultrasound device that uses advanced imaging modes like Doppler, elastography, and speckle tracking to provide high-quality ultrasound images of various body parts including fetal, abdominal, cardiac, and musculoskeletal regions. It aids clinicians by providing detailed images to support diagnosis and clinical evaluation in hospitals and clinics.

The Ultrasound Imaging System (LU700, 128, and LX Series) by Leltek Inc. is a portable, software-controlled ultrasound system that runs on commercial mobile devices. It uses wireless transducers communicating over Wi-Fi to acquire and display real-time, high-resolution ultrasound images across multiple modes such as B-mode and Doppler modes. It aids clinicians in evaluating various body regions and conditions by providing versatile imaging capabilities tailored for different probes and clinical applications.

The Lumify Diagnostic Ultrasound System by Philips Ultrasound is a mobile, software-controlled ultrasound imaging device that supports various imaging modes including B-mode, Color Doppler, Pulsed Wave Doppler, and M-mode. It is designed for diagnostic ultrasound imaging and fluid flow analysis across many anatomical areas such as fetal, abdominal, musculoskeletal, cardiac, ophthalmic, and more. The device is compatible with iOS and Android systems and includes different USB transducers. The recent update adds an ocular preset to enable ophthalmic imaging, expanding its clinical utility. This portable ultrasound system helps clinicians obtain high-resolution images and flow data to support diagnosis and procedural decisions.

The eHertz Functional Series Diagnostic Ultrasound System by eSonic Technology is a portable ultrasound imaging device designed for general diagnostic use across adults, pregnant women, and pediatric patients. It supports multiple imaging modes including B-mode, Doppler, and elastography among others, enabling healthcare professionals to visualize and analyze the human body and fluid for various exams such as fetal, abdominal, cardiac, and musculoskeletal. This system enhances image quality through features like micro blood flow imaging and image optimization, aiding clinicians in making more accurate assessments.

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced diagnostic ultrasound imaging systems used in various clinical settings, including hospitals and clinics. They provide imaging and fluid flow analysis of multiple body regions through modes like B Mode, Doppler, and Harmonic Imaging, helping clinicians diagnose a wide range of conditions. A new Remote Software Management feature enhances workflow by allowing remote software upgrades and maintenance, improving system availability and usability without hardware changes.

The Acclarix AX8 and AX9 Series Diagnostic Ultrasound Systems by Edan Instruments are advanced ultrasound imaging devices used by clinicians for a wide range of clinical applications including abdominal, cardiac, musculoskeletal, and vascular imaging among others. These systems support multiple imaging modes such as B mode, Doppler, harmonic imaging, elastography, and contrast imaging, aiding healthcare professionals in acquiring and interpreting ultrasound data to diagnose and monitor patient conditions effectively.

The Vivid T9/Vivid T8 is a diagnostic ultrasound system primarily intended for cardiac imaging but also supports vascular and general radiology applications. It provides digital acquisition, processing, measurement, display, and analysis of ultrasound images using various transducers and imaging modes. The system supports a range of clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, helping healthcare professionals in hospitals and clinics obtain real-time detailed images for diagnostic purposes.

The Vivid iq is a high-performance compact diagnostic ultrasound system designed primarily for cardiovascular and shared services imaging, but also applicable to various clinical areas such as fetal, abdominal, pediatric, musculoskeletal, and vascular imaging. It supports multiple ultrasound modes including Doppler and real-time 3D imaging. The system aids healthcare professionals by providing advanced ultrasound imaging and analysis capabilities for better diagnosis and patient care.