FDA Radiology AI Devices

The Flash Ultrasound System 5100 Point of Care by Philips Ultrasound LLC is a diagnostic ultrasound system designed for point-of-care use. It offers multimodal ultrasound imaging including B-mode, Doppler, and M-mode for a wide range of anatomical regions and clinical settings, enabling clinicians to perform fluid flow analysis and image diagnostics efficiently in environments like hospitals, emergency rooms, and outpatient clinics. This system helps healthcare professionals make faster and well-informed clinical decisions using advanced ultrasound technology in a compact and user-friendly device.

Kosmos by EchoNous, Inc. is an imaging system that uses pulsed Doppler ultrasound technology to assist radiology professionals in medical imaging. It helps clinicians by providing detailed ultrasound images for diagnostic purposes involving blood flow and tissue imaging.

The NUSONO Handheld Ultrasound Scanner is a portable, software-driven ultrasound imaging system that interfaces wirelessly with mobile devices to provide high-resolution diagnostic imaging in various clinical applications. It supports multiple imaging modes, including B-mode, M-mode, Color Doppler, and Power Doppler, enabling healthcare professionals to effectively diagnose conditions across fetal, abdominal, pediatric, urology, gynecology, cardiac, and lung areas. By integrating with smartphones and tablets, it offers flexible, real-time imaging solutions for use in clinics, hospitals, and point-of-care settings, enhancing diagnostic confidence and accessibility.

The EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced diagnostic ultrasound devices that use AI-powered AutoMeasure V3 software to provide semi-automated 2D, Doppler, and M-mode measurements for adult echocardiography. These systems help healthcare professionals efficiently perform and analyze cardiac ultrasound exams, improving measurement accuracy and workflow in clinical environments such as hospitals and clinics.

The Digital Color Doppler Ultrasound System (P60 Series) by Sonoscape Medical Corp. is an advanced ultrasound imaging instrument that uses multiple modes including color Doppler and AI-based features to help clinicians evaluate a wide range of body regions and conditions with high detail and accuracy. It supports AI-powered automatic recognition and measurement to aid in fetal ultrasound examinations and other diagnostic exams, improving workflow efficiency and diagnostic performance.

The EVIS EUS Endoscopic Ultrasound Center Olympus EU-ME3 is a real-time endoscopic ultrasound imaging system designed to be used with Olympus ultrasound endoscopes and probes. It captures ultrasound images within various internal organs such as the gastrointestinal tract, biliary and pancreatic ducts, and others. The system supports various ultrasound modes including B mode, Doppler modes, harmonic imaging, elastography, and shear wave quantification to provide comprehensive diagnostic information, helping clinicians in diagnosis and treatment planning.

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 ACUSON Redwood Diagnostic Ultrasound System is a multi-purpose ultrasound device designed for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and more. It uses advanced ultrasonic pulsed Doppler and various imaging modes to help healthcare professionals visualize internal body structures and measure anatomical features, assisting in clinical diagnosis and patient management, such as assessing liver fat content. It supports both 2D and advanced combined imaging modes and integrates specialized features like Ultrasound-Derived Fat Fraction (UDFF) for aiding in hepatic steatosis evaluation.

The 5000 Compact Series Ultrasound Systems by Philips Ultrasound LLC is a diagnostic ultrasound imaging system equipped with an AI-powered Auto Measure feature. It provides semi-automated, editable 2D and Doppler measurements primarily for adult echocardiography, helping clinicians obtain accurate cardiac measures efficiently. The system supports a wide range of clinical applications including cardiac, abdominal, vascular, obstetric, and musculoskeletal imaging, and is used in various clinical settings such as hospitals and clinics.

The Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) by Telefield Medical Imaging is a portable, software-controlled ultrasound system designed for real-time visualization of anatomical structures and blood flow using B-mode, color Doppler, and pulsed wave imaging. It aids healthcare professionals by providing detailed imaging and fluid flow analysis across multiple body regions such as abdominal, musculoskeletal, and vascular areas, facilitating diagnosis at the point of care.