FDA Radiology AI Devices

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.

Bladder AI is a software designed to assist healthcare providers in measuring bladder volume from ultrasound images using machine learning. It supports image-based assessment, landmark placement, and report generation for patients aged 2 years and older, improving workflow efficiency and accuracy in bladder volume quantification.

The Voluson SWIFT and Voluson SWIFT+ are advanced diagnostic ultrasound systems used by healthcare professionals for imaging and analyzing the human body and fluids. These systems support multiple clinical applications including fetal/obstetrics, abdominal, cardiac, musculo-skeletal, and vascular imaging using various ultrasound modes such as B-mode, Doppler, 3D/4D imaging, and elastography. They feature AI-assisted tools like Auto-Caliper for improved measurement accuracy, enhancing clinicians' ability to perform exams efficiently and precisely in hospital or clinical settings.

The EPIQ Series Diagnostic Ultrasound System by Philips Ultrasound LLC is a diagnostic ultrasound imaging device used to visualize and analyze fluid flow in the human body. It supports a wide range of clinical applications including abdominal, cardiac, vascular, musculoskeletal, and ophthalmic imaging, enhancing clinicians' ability to diagnose and guide treatment with high-resolution imaging and fluid flow analysis.

The Lumify Diagnostic Ultrasound System by Philips Ultrasound is a transportable ultrasound device that provides high-resolution diagnostic imaging across various modes including B-mode, Doppler, and M-mode. It incorporates an AI-based software feature that automatically detects and quantifies lung B-lines and merged B-lines from ultrasound videos to assist clinicians in assessing lung conditions such as pneumonia and pulmonary edema. The system supports multiple transducers and is designed for use by healthcare professionals in diverse clinical settings.

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.

Velacur is a portable ultrasound device that measures the stiffness and attenuation of liver tissue by generating and analyzing shear waves using ultrasound imaging. It incorporates AI-based algorithms to assist clinicians in assessing liver disease by providing detailed tissue characterization, enhancing accuracy and ease of use at the point of care in clinics and hospitals.

Ultrasound System 2300 is a mobile, software-controlled diagnostic ultrasound system designed for a wide range of clinical applications including fetal, abdominal, pediatric, neuro, cardiac, and musculoskeletal imaging among others. It supports multiple ultrasound modes such as B-Mode, Doppler, Elastography, and Contrast Imaging to assist qualified healthcare professionals in imaging and guiding puncture and biopsy procedures, thereby improving diagnostic confidence and procedural accuracy.