FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

TINGSN FINDERS 2 is a color Doppler ultrasound system that helps clinicians visualize and assess blood flow and heart function using pulsed Doppler ultrasound technology. It assists in cardiovascular diagnosis by providing detailed images and flow information in real time.

FDA #
K250913
Product Code
IYN

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are sophisticated diagnostic ultrasound devices that integrate deep learning AI technology to assist clinicians in cardiac imaging. Their Smart View Select software automatically classifies and selects optimal ultrasound images for left ventricle analysis in echocardiography, enhancing workflow and diagnostic accuracy for cardiac assessment. These systems are used by trained healthcare professionals in clinics and hospitals for a broad range of diagnostic ultrasound applications.

FDA #
K250886
Product Code
IYN

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.

FDA #
K240676
Product Code
IYN

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.

FDA #
K242523
Product Code
IYN

LOGIQ Totus is a comprehensive diagnostic ultrasound system designed for use by trained healthcare professionals. It offers imaging, measurement, display, and analysis for a wide range of clinical applications, including obstetrics, abdominal, cardiac, vascular, and musculoskeletal imaging. The system supports multiple ultrasonic imaging modes and integrates AI-enabled features such as auto preset selection and auto abdominal color assistant to improve efficiency and accuracy in clinical settings.

FDA #
K232381
Product Code
IYN

The Vivid iq is a high-performance compact diagnostic ultrasound system designed for cardiovascular and shared service imaging. It assists healthcare professionals in ultrasound imaging, measurement, display, and analysis of human body and fluid, across a wide range of clinical applications including fetal, cardiac, abdominal, musculoskeletal, and vascular imaging. It incorporates advanced ultrasound modes such as Doppler, color Doppler, harmonic imaging, and real-time 3D imaging, supporting various transducers and enabling flexible clinical use in hospital and office environments.

FDA #
K221148
Product Code
IYN

The Philips EPIQ and Affiniti Diagnostic Ultrasound Systems are advanced ultrasound machines that provide diagnostic imaging and fluid flow analysis for various body regions. They help clinicians visualize internal organs and blood flow in real time, assisting in the diagnosis and treatment of conditions related to the abdomen, heart, brain, musculoskeletal system, and more. The system also includes liver fat quantification tools to measure attenuation and hepato-renal index, supporting assessment of liver health.

FDA #
K212704
Product Code
IYN

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound imaging devices used across multiple clinical applications including fetal, abdominal, cardiac, and musculoskeletal imaging. They incorporate AI-powered features such as HeartAssist and BiometryAssist to improve efficiency and accuracy by automatically identifying scanning views and aiding biometric measurements. These devices assist clinicians by providing comprehensive ultrasound imaging modes and enhancing workflow in hospitals and clinics.

FDA #
K211824
Product Code
IYN
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