FDA Radiology AI Devices

Auto Segmentation by GE Medical Systems is an AI software tool that automatically generates organ-at-risk contours from CT scans to help radiation oncologists, medical physicists, and dosimetrists speed up radiation therapy planning. It produces initial segmentation contours that users can review and adjust, improving workflow efficiency and precision in radiation treatment.

The SIS System is a software tool that uses advanced machine learning and image processing to help surgeons, neurologists, and radiologists visualize critical brain structures in 3D. It assists in planning neurological procedures such as Deep Brain Stimulation by creating detailed anatomical models from MRI images and localizing implanted leads on post-operative CT images, improving accuracy and surgical outcomes.

MR DWI/FLAIR Measurement V1.0 is a medical image processing software developed by Olea Medical that analyzes MRI brain images from diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR) sequences. It automatically computes diffusion maps and extracts relevant metrics to assist medical professionals in evaluating brain conditions. The software integrates with existing medical imaging platforms and helps clinicians by providing quantitative analysis to complement their diagnosis and treatment planning.

Ceevra Reveal 3 is a software medical device designed for processing, reviewing, and analyzing 3D images created from CT and MR scans. It helps clinicians with preoperative surgical planning and intraoperative image display, including interacting with 3D visualizations using mobile or desktop viewers, and even VR headsets. By using AI-driven algorithms, it generates preliminary segmentations of normal anatomical structures to assist healthcare professionals in their clinical decisions for adult patients.

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound devices for diagnostic imaging and fluid analysis of the human body. They support numerous clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging. These systems incorporate various imaging modes such as 2D, 3D, Doppler, and elastography, and include AI-powered features like BiometryAssist and ViewAssist that help with anatomical measurements and view recognition, aiding clinicians in making accurate diagnoses.

Velacur is a portable ultrasound device that measures the stiffness and attenuation of liver tissue by generating and analyzing shear waves using ultrasound imaging. It incorporates AI-based algorithms to assist clinicians in assessing liver disease by providing detailed tissue characterization, enhancing accuracy and ease of use at the point of care in clinics and hospitals.

ART-Plan is a medical imaging software that helps clinicians visualize, contour, and process 3D multi-modal images like CT, MR, and PET-CT for cancer patients undergoing radiotherapy. The software uses AI to automatically delineate organs at risk and lymph nodes to assist in treatment planning, saving time and improving precision. It also supports image registration and generation of synthetic CT images from MRI.

Quantib Prostate is a software tool that helps medical professionals analyze prostate MRI images. It automatically segments the prostate and its subregions, supports visualization with multiparametric MRI, and assists in identifying and editing potential lesions. By streamlining these tasks, it aids radiologists in interpreting prostate MRI studies more efficiently and effectively.

AutoContour Model RADAC V3 is an AI-enabled software designed to automatically contour anatomical structures in CT and MR images to assist radiation treatment planners in preparing radiation therapy plans more efficiently. It uses deep learning models to generate contours of organs and tumors, allowing clinicians to review and adjust as needed, which streamlines the treatment planning process and improves accuracy.

Limbus Contour is a software tool that automatically segments CT and MRI images to help radiation oncologists, dosimetrists, and medical physicists create precise contours of healthy anatomical structures. These contours are used as inputs for radiation treatment planning, improving accuracy and efficiency in therapy. The software integrates with existing treatment planning systems and image viewers, assisting in contour creation, modification, and management without displaying images directly.