FDA Radiology AI Devices

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound machines designed to capture and display ultrasound imaging including B-mode, Doppler modes, 3D/4D imaging, and provide measurement and analysis tools to assist healthcare professionals in diagnosing various conditions. They support a wide range of clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more, helping clinicians in hospitals and clinics perform accurate diagnostic imaging and fluid analysis efficiently.

Customize is a software tool designed to assist physicians in planning shoulder arthroplasties by visualizing, modifying, and validating 3D models generated from CT scans. It helps communicate treatment options, segments CT data, and manages cases and timelines, aiding clinicians in surgical preparation and decision-making.

Arterys MICA is a cloud-based medical imaging software that helps healthcare professionals view, process, and analyze medical images from CT and MRI scans. It includes AI modules that assist in cardiac and oncology evaluations by automating image quantification and lesion assessments, supporting clinicians in their diagnostic workflows.

Contour ProtégéAI by MIM Software Inc. is an AI-powered software tool that helps trained medical professionals automatically create contours of anatomical structures on CT and MRI scans. The software uses machine-learning algorithms to segment normal organs and tissues, aiding in quantitative analysis and radiation therapy planning. It is intended to improve workflow efficiency and treatment accuracy by automating tedious contouring tasks.

syngo.CT Extended Functionality is a software suite from Siemens that provides advanced visualization tools for CT and possibly MRI medical images. It helps technicians and physicians perform qualitative and quantitative measurements, facilitates advanced clinical evaluations using various extensions, and supports processing to aid in diagnosis.

Quantib ND is a software application that automatically labels, visualizes, and measures volumes of brain structures and white matter abnormalities from MR brain scans. It helps radiologists by providing detailed quantitative data and visual segmentations to assist in assessing and tracking neurological conditions.

VBrain is a software tool that helps medical professionals in planning radiation therapy for brain tumors. It uses artificial intelligence, specifically deep learning neural networks, to automatically outline brain tumors and organs at risk on MRI scans of the brain. This assists clinicians by providing initial contours that they can review and adjust, improving workflow efficiency and accuracy in treatment planning.

RT-Mind-AI is a software tool designed to automatically segment organs-at-risk in non-contrast CT images for patients undergoing radiation therapy. It helps radiation oncologists by providing accurate anatomical contours that support treatment planning and evaluation, improving workflow and precision.

LVivo Seamless is an AI-powered software application that analyzes ultrasound (echocardiogram) images to automatically detect heart structures, measure ejection fraction (EF), and calculate global longitudinal strain (GLS), aiding clinicians in assessing cardiac function efficiently and accurately. It runs offline on a server in healthcare settings, accepts DICOM-format ultrasound clips from various vendors, and sends results to PACS for professional review.

Al-Rad Companion (Pulmonary) is an AI-powered software by Siemens that processes CT images of the lungs to assist clinicians in quantitatively and qualitatively analyzing lung diseases. It segments lungs and lobes, detects lung lesions and areas of abnormal tissue density, and provides measurements to support radiologists and physicians in emergency, specialty, and general care settings. This helps streamline and improve lung disease evaluation.