FDA Radiology AI Devices

HealthOST is an AI-powered image processing software that analyzes CT scans of the spine to help clinicians detect and assess musculoskeletal diseases in patients aged 50 and older. It labels vertebrae, measures vertebral height loss, and calculates bone density using Hounsfield Units, providing quantitative data to aid diagnosis and treatment planning without replacing clinical judgment.

AI-Rad Companion Brain MR is software that assists clinicians by automatically analyzing brain MRI scans. It segments various brain structures, quantifies their volumes, and highlights white matter hyperintensities, comparing results to normal data. This helps radiologists make more accurate and efficient evaluations of brain health.

INTContour is a software tool that uses machine learning to automatically identify and outline organs and treatment targets on medical images to aid radiation therapy planning. This helps clinicians by providing initial segmentations that can be reviewed and edited, saving time and improving efficiency in treatment preparation for cancer patients.

ClariPulmo is a software tool designed to analyze lung CT images. It helps doctors by automatically segmenting the lungs and quantifying areas of low and high attenuation in the lung tissue. It includes AI-based features like deep learning segmentation, denoising, and kernel normalization to improve image quality and quantification, especially for low-dose CT scans. This software supports clinical assessment of lung abnormalities by providing color-coded images and quantitative reports.

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.