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 Voluson™ Performance 16 and Voluson™ Performance 18 are advanced diagnostic ultrasound systems designed for use by trained healthcare professionals to image, measure, display, and analyze human body structures and fluids. These systems support a wide range of clinical applications including fetal/obstetrics, abdominal, pediatric, small organ, cardiac, vascular, musculoskeletal, and more. They provide real-time 3D/4D imaging, various Doppler modes, elastography, and have integrated AI features to assist in analysis. These systems enhance clinicians' ability to perform ultrasound examinations efficiently and with high image quality, aiding patient diagnosis and care.

DEEPECHO is a cloud-based AI software for fetal ultrasound image analysis. It helps trained healthcare professionals detect important fetal views in ultrasound scans and suggests caliper placement for accurate biometric measurements like head circumference and femur length. The software supports real-time image streaming and exam management to improve fetal assessment during pregnancy between 14 and 41 weeks, aiding clinicians to make informed decisions efficiently.

The EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced ultrasound systems designed for diagnostic imaging and fluid flow analysis across multiple body regions. They include an AI software feature called R-Trigger that detects R-wave peaks from cardiac cycles without requiring ECG input, aiding automated cardiac measurements to simplify and improve workflow for clinicians during transthoracic echo exams.

The Diagnostic Ultrasound System (including models Recho R9W, Recho R9, and others) by Shenzhen Mindray Bio-medical Electronics Co., Ltd. is a general-purpose, mobile ultrasound imaging system. It helps trained healthcare professionals acquire and display ultrasound images in multiple modes like B, M, Doppler, 3D/4D, elastography, and contrast imaging, aiding in the diagnosis and analysis of various body regions in adults, pediatric patients, pregnant women, and neonates.

The 6450 Ultrasound System (MyLabE80 and MyLabE85) is a versatile diagnostic ultrasound machine designed for various clinical applications including cardiac, vascular, general imaging, and women's health. It supports multiple ultrasound modes like B-mode, Doppler, elastosonography, and 3D/4D imaging to help clinicians visualize and assess internal body structures in real-time, aiding in diagnosis and treatment planning.

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 Philips Lumify Diagnostic Ultrasound System is a portable medical ultrasound device that allows clinicians to capture high-resolution ultrasound images and analyze blood flow in various body regions. It supports multiple imaging modes and is compatible with mobile devices, helping healthcare professionals perform diagnostic ultrasound in many clinical applications, including obstetrics, gynecology, musculoskeletal, cardiac, and vascular imaging. The addition of the C9-4ec transducer expands its use to trans-vaginal imaging and fertility assessments, improving diagnostic capabilities in reproductive health.

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 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.