FDA Radiology AI Devices

EchoPAC Software Only / EchoPAC Plug-in is a software platform designed for diagnostic review, analysis, and reporting of ultrasound images. It allows post-processing of raw data from GE ultrasound scanners and DICOM ultrasound images, supporting multiple clinical applications like fetal, cardiac, abdominal, and musculoskeletal imaging. The software helps clinicians manage patient records and generate detailed reports efficiently.

The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also applicable to vascular and general radiology. These systems use ultrasound technology to capture, process, and analyze images of the human body, aiding clinicians in precise measurements and display of ultrasound data. They include features such as 3D imaging, Doppler modes, and AI-assisted tools like Easy Auto EF and Easy AFI LV for enhanced image analysis, improving workflow and diagnostic accuracy for healthcare professionals.

Libby Echo:Prio is a software tool that processes DICOM-compliant cardiac ultrasound images to provide automated measurements and analysis of cardiac function, such as ejection fraction and heart rate. It supports cardiologists and sonographers by automating view classification, border segmentation, and generating quantification reports, thus aiding clinical decision-making in cardiac care.

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.

The Vivid T8 and Vivid T9 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also supporting vascular and general radiology applications. They provide digital acquisition, processing, analysis, and image display, and incorporate AI algorithms such as Easy Auto EF and Easy AFI LV that assist clinicians by automating measurements and analysis of cardiac function, improving workflow and diagnostic accuracy.

The Vivid S60N and Vivid S70N are advanced, general-purpose ultrasound systems specialized for cardiac imaging, but also supporting multiple other clinical applications such as abdominal, vascular, and musculoskeletal imaging. They provide digital ultrasound image acquisition, processing, analysis, and display with various transducer options and imaging modes. The systems include AI-powered features like Easy Auto EF and Easy AFI LV for automated cardiac function assessment to assist clinicians in evaluating heart health efficiently.

The V8 and V7 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound imaging systems designed for a wide range of clinical applications including obstetrics, abdominal, cardiac, musculoskeletal and more. They produce ultrasound images and enable fluid analysis, incorporating features like Doppler imaging and AI-supported nerve detection to help clinicians make accurate diagnoses in real-time.

Venue Fit is a compact, portable diagnostic ultrasound system designed for use by trained healthcare professionals. It provides high-quality ultrasound imaging and fluid flow analysis across multiple clinical applications. The system supports standard ultrasound modes and includes AI-assisted features such as nerve tracking to help clinicians during procedures. Venue Fit enhances imaging capabilities and workflow efficiency in hospital and clinical settings.

Venue by GE Medical Systems is a general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It offers ultrasound imaging, measurement, and analysis of the human body and fluids in a variety of clinical settings including hospitals and clinics. The device supports multiple clinical applications across different body regions and features automated tools to improve clinical workflow. Venue also includes AI-powered tools such as cNerve which assists in nerve detection and tracking during nerve block procedures, enhancing precision and patient safety.

Venue Go is a portable, general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals to image and analyze the human body and fluid flow. It supports a wide range of clinical applications including abdominal, cardiac, vascular, musculoskeletal, and more. It offers advanced imaging modes and AI-enhanced tools such as cNerve for nerve tracking, aiding clinicians during procedures like nerve blocks. This device helps clinicians obtain high-quality ultrasound images and analyze them efficiently to improve patient care.