FDA Radiology AI Devices

The Falcon/Xpress is a compact, portable ultrasonic diagnostic device designed for the noninvasive evaluation of peripheral vascular conditions. It uses pneumatic pressure measurements, Doppler ultrasound, and photo-plethysmography to assess blood flow and vascular health in various limb sites. This helps clinicians diagnose vascular diseases and monitor vascular function with specialized testing protocols.

The ULTIMUS Series Ultrasound Diagnostic System by Vinno Technology (Suzhou) Co., Ltd is a mobile diagnostic ultrasound system designed to assist qualified physicians in imaging and analyzing various parts of the human body and fluids. It supports multiple clinical applications including abdominal, fetal/obstetrics, gynecology, cardiac, vascular, musculoskeletal, and pediatric imaging with advanced imaging modes like 3D/4D, Doppler, elastography, and contrast imaging. The system provides high-quality ultrasound imaging and measurement capabilities intended for hospitals and clinics to enhance diagnostic confidence and patient management.

Laminar P1 is a wearable and disposable ultrasound patch sensor designed to detect blood flow in peripheral vessels to help identify peripheral vascular disease. It is intended for use by healthcare professionals in various settings and offers a compact alternative to traditional Doppler ultrasound probes, providing audio output and selectable sensitivity settings to aid clinical assessments.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips are advanced ultrasound imaging systems used for a wide range of diagnostic applications across many body regions. The newly introduced Auto ElastQ software feature assists clinicians by automatically selecting the most stable frames and regions of interest for liver stiffness measurements with 2D shear wave elastography, making the diagnostic workflow easier and potentially more reliable. This helps healthcare professionals to assess liver tissue characteristics more efficiently during ultrasound exams.

The V5 and H5 series diagnostic ultrasound systems from Samsung Medison are advanced ultrasound imaging devices that provide real-time images and Doppler analysis to assist healthcare professionals in clinical diagnosis across a broad range of applications including obstetrics, cardiology, musculoskeletal, and dermatology. These systems use AI-powered tools for tasks like view recognition, segmentation, and measurement, enhancing accuracy and efficiency in ultrasound examinations.

The Readius series (L15, P8, V6, C6) are digital color Doppler ultrasound imaging systems designed for diagnostic use by qualified physicians. They support various scanning modes to image abdominal areas, small organs like the thyroid and breast, and peripheral vascular structures. The systems enable B-mode, M-mode and advanced Doppler flow imaging to assist clinicians in evaluating blood flow and tissue characteristics in real time.

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound imaging devices used to visualize and analyze structures within the human body. They support diverse clinical applications including obstetrics, cardiology, abdominal imaging, and musculoskeletal imaging through multiple ultrasound modes such as 2D, Doppler, and 3D/4D. The systems incorporate AI technologies to assist clinicians in fetal biometry and cardiac view recognition, helping improve diagnostic accuracy and workflow efficiency.

Sonix Health is a software product designed to analyze echocardiography ultrasound images automatically. It helps clinicians by classifying ultrasound views and measuring cardiac parameters using AI, thereby improving efficiency and accuracy in heart assessment for adult patients.

Strain AI is a medical software device that analyzes cardiac ultrasound images to measure global longitudinal strain (GLS), helping clinicians assess heart function in adult patients. It integrates with existing ultrasound devices to provide quantitative strain measurements, supporting diagnostic evaluation without requiring manual interpretation of images.

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems by Siemens are advanced diagnostic ultrasound devices that provide detailed imaging and signal data inside the body for clinical diagnosis. They are intended for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and pediatric imaging. These systems integrate AI-powered tools such as AI Abdomen for semi-automated view classification and measurement in abdominal ultrasound, and Trace AI for semi-automated measurements of anatomical structures in cardiac imaging, improving efficiency and accuracy for clinicians.