FDA Radiology AI Devices

Deep Learning Image Reconstruction by GE Healthcare Japan Corporation is a deep learning based software integrated into CT scanners to reconstruct high-quality cross-sectional images of the head, whole body, cardiac, and vascular systems. It uses a trained deep neural network to reduce image noise and artifacts while maintaining spatial resolution, aiding clinicians in obtaining clearer diagnostic images with routine CT throughput.

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.

Ezra Flash is a software tool that uses AI (convolutional neural networks) to enhance brain MRI images by reducing noise. It supports 3-Tesla Siemens and GE MRI scanners for specific sequences, providing clearer images to assist radiologists in diagnosis without altering the original images.

CerebralGo Plus is a software package designed for trained medical professionals to view and process CT Angiography images of the head and neck. It helps visualize large vessels from adult CTA scans to support clinical decisions, although it is not intended for primary diagnostic use. The software integrates with standard DICOM-compliant imaging devices and hospital systems to facilitate image management and processing.

Ultrasound System 2300 is a mobile, software-controlled diagnostic ultrasound system designed for a wide range of clinical applications including fetal, abdominal, pediatric, neuro, cardiac, and musculoskeletal imaging among others. It supports multiple ultrasound modes such as B-Mode, Doppler, Elastography, and Contrast Imaging to assist qualified healthcare professionals in imaging and guiding puncture and biopsy procedures, thereby improving diagnostic confidence and procedural 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.

AI-Rad Companion (Cardiovascular) is a software product that uses AI and deep learning to analyze previously acquired chest CT images, providing quantitative and qualitative assessments of cardiovascular structures like the heart and aorta. It helps clinicians by automating segmentation, volume measurement, calcium quantification in coronary arteries, and diameter measurements of the aorta, thus supporting accurate and efficient cardiovascular disease evaluation.

Contour ProtégéAI is a medical imaging software accessory designed to assist trained medical professionals by automatically creating anatomical contours on CT and MR images using machine learning. It helps in radiation therapy planning by segmenting various body structures, including the prostate and pelvic organs, enabling quantitative analysis, adaptive therapy, and patient follow-up. Results generated by the AI can be reviewed and edited to ensure accuracy.