FDA Radiology AI Devices

Versana Premier is a general purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It supports multiple clinical applications such as fetal, abdominal, gynecological, cardiac, vascular, musculoskeletal, and more. It includes various advanced imaging modes and features AI-based enhancements like Whizz Label to assist clinicians in acquiring and interpreting ultrasound images efficiently and accurately. The system is intended for hospitals and medical clinics to aid in the diagnosis and assessment of medical conditions.

The Aquilion Exceed LB is a whole-body multi-slice helical CT scanner that captures detailed cross-sectional images of the body, including the head. It incorporates AiCE, an AI-based noise reduction algorithm using deep convolutional neural networks, to improve image quality and reduce noise. This helps clinicians obtain clearer, more accurate diagnostic images for various body regions, including abdomen, pelvis, lung, cardiac, extremities, head, and inner ear.

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.

FEops HEARTguide is a software tool that helps clinicians simulate and plan the implantation of left atrial appendage occlusion devices in individual patients. By using CT scans to create patient-specific heart models and incorporating device mechanics, it predicts how the device will deform and interact with the tissue, aiding pre-procedural decision-making to improve procedural outcomes and device placement.

RayStation 11.0 is a software system used in radiation therapy and medical oncology for planning, analyzing, and administering treatment plans. It helps clinicians design and optimize radiation treatments accurately based on the patient's medical imaging data, enhancing treatment effectiveness and safety.

The Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems are advanced ultrasound imaging devices used to capture diagnostic ultrasound images and analyze fluid flow in various parts of the human body. These systems include an AI-powered Auto Measure feature that semi-automates 2D and Doppler measurements during echocardiography, helping clinicians perform more efficient and standardized assessments with editable, semi-automated results.

AmCAD-UT is a Windows-based AI-assisted software designed to help clinicians analyze thyroid ultrasound images. After initial review by a physician, the software quantifies and visualizes sonographic features of thyroid nodules, specifically those larger than 1cm, aiding in clinical decision-making for biopsy recommendations. It facilitates detailed image analysis and generates automated reports to support thyroid cancer diagnosis and management.

The V8 Diagnostic Ultrasound System by Samsung Medison is a general-purpose, mobile ultrasound device that captures real-time images and analyzes body fluids across various clinical applications including obstetrics, cardiac, abdominal, and musculoskeletal imaging. It uses multiple imaging modes and some AI-based software features to assist clinicians in diagnosis and measurement, helping improve accuracy and efficiency in medical imaging.

AI Segmentation is a cloud-based software product that uses artificial intelligence to automatically segment anatomical structures from CT images. It is designed to assist medical professionals in radiation therapy treatment planning by providing automated contours of organs in regions such as the head and neck, thorax, pelvis, and abdomen. The segmented structures can be reviewed, edited, and approved by qualified treatment planners and physicians to streamline planning and improve accuracy.

Auto Lung Nodule Detection is a computer-aided detection software designed by Samsung Electronics to assist physicians in identifying and marking suspected pulmonary nodules between 10 and 30 mm on PA chest X-rays. Integrated into Samsung's digital X-ray systems, it serves as a second reader by highlighting regions of interest on images to support radiologists in their interpretation and improve detection accuracy.