FDA Radiology AI Devices

BoneMRI v1.6 is an AI-powered software that enhances MRI images to improve visualization of bone structures in the pelvic and lumbar spine regions. It uses advanced algorithms, including convolutional neural networks, to generate 3D images with enhanced bone contrast. This allows clinicians such as radiologists and orthopedic surgeons to better assess bone morphology and tissue density without the need for CT scans, improving diagnostic capabilities in these regions.

The uMR 680 is a 1.5 Tesla superconducting magnetic resonance imaging (MRI) system designed to produce diagnostic-quality images of the head, body, and extremities. It includes a deep-learning based image processing algorithm called DeepRecon for image denoising and super-resolution, enhancing image quality and assisting clinicians in diagnosis.

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is an advanced CT scanner designed to produce cross-sectional images of various body regions, including head, whole body, cardiac, and vascular areas. It integrates deep learning for image reconstruction to enhance image quality and reduce noise, and includes software for dual energy analysis to differentiate tissue types based on their chemical composition. This aids clinicians in lung cancer screening and detailed anatomical evaluation, supporting early diagnosis and treatment.

The V8 and V7 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound machines designed for a wide range of clinical applications including fetal, abdominal, musculoskeletal, cardiac, and more. They use various ultrasound imaging modes and AI-based tools to assist healthcare professionals in acquiring and analyzing ultrasound images for improved diagnosis and workflow efficiency.

The SIGNA Victor is a 1.5 Tesla whole body MRI scanner designed to provide high-resolution diagnostic images quickly and with a high signal-to-noise ratio. It produces images in multiple planes and supports imaging of the entire body, including brain, spine, joints, heart, abdomen, and more, aiding clinicians in diagnosing a variety of conditions.

Videa Perio Assist is an AI-powered software that helps dentists and dental hygienists measure and visualize bone levels between teeth using bitewing and periapical dental X-rays. It provides precise measurements that support evaluations related to periodontal health but is not meant to replace full clinical diagnosis.

Oncospace is a software tool that assists radiation oncologists and medical dosimetrists in planning radiotherapy treatments for patients with cancer in the prostate, head, and neck regions. It uses locked machine learning algorithms to predict achievable dose objectives for organs at risk based on the patient's anatomy and automates aspects of treatment plan optimization. This helps clinicians customize treatment protocols, optimize radiation dose delivery while sparing healthy tissue, and review treatment plans efficiently, ultimately supporting better patient care in radiation oncology.

LVivo IQS is a software application that processes ultrasound images of the heart to detect, measure, and calculate key medical parameters for patients with suspected cardiac disease. It provides real-time quality score feedback on image quality, helping clinicians ensure the accuracy and usefulness of cardiac ultrasound scans, particularly the left ventricle function from the 4 chamber apical view. This tool assists clinicians by improving the reliability of echocardiographic assessments.

Rapid RV/LV is a medical imaging software designed to assist clinicians by automatically measuring the sizes of the right and left heart ventricles from CT pulmonary angiography scans. It provides annotated images and quantitative measurements to help assess right-heart strain, supporting clinical decision-making in cardiopulmonary conditions. The software uses machine learning to locate the ventricles and report their size ratio.

BriefCase is an AI-powered software by Aidoc Medical that automatically analyzes chest CT scans to identify cases with three or more acute rib fractures. It sends notifications with preview images to help radiologists prioritize these critical cases for faster review, enhancing clinical workflow and patient care without altering original images or providing primary diagnoses.