FDA Radiology AI Devices

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.

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.

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.

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.

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.

EndoNaut is a medical imaging software system that helps doctors during endovascular procedures by overlaying three-dimensional vessel images from preoperative scans onto real-time two-dimensional fluoroscopy images. This assists clinicians in accurately positioning catheters, guidewires, and stents within blood vessels in areas like the thorax, abdomen, pelvis, and lower limbs, improving procedural outcomes and patient care.

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.

RBknee is an AI-powered software that automatically analyzes knee X-ray images to measure joint space width and assess signs of knee osteoarthritis. It provides objective measurements and standardized grading to help medical professionals in evaluating knee osteoarthritis severity, supporting diagnosis and treatment decisions.

The Discovery MI Gen2 is a PET/CT imaging system by GE Medical Systems designed to produce detailed attenuation-corrected PET images combined with CT scans. It helps clinicians by providing anatomically localized images of radiopharmaceutical distribution, aiding diagnosis, treatment planning, and monitoring of diseases such as cancer, neurological disorders, and cardiac conditions across various body regions.