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.

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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