FDA Radiology AI Devices

The Aquilion Precision (TSX-304A/4) V10.10 with AiCE is a whole-body CT scanner with ultra-high resolution that uses advanced AI deep convolutional neural networks to reduce image noise and enhance image quality, particularly for abdominal, pelvic, lung, and cardiac scans. It helps clinicians obtain clearer, more detailed images while potentially reducing radiation dose, thereby improving diagnostic confidence and patient care.

Rapid ICH by iSchemaView Inc. is a medical software that uses artificial intelligence to analyze head CT scans for signs of intracranial hemorrhages such as IPH, IVH, SAH, and SDH. It helps hospitals and radiologists prioritize CT images needing urgent attention by providing notifications about suspected hemorrhages, enabling faster diagnosis and treatment without altering the original medical images or replacing diagnostic interpretation.

The EFAI ChestSuite XR Pleural Effusion Assessment System is an AI-powered software tool designed to assist radiologists by analyzing adult chest X-ray images (taken in the PA view) to identify features suggestive of pleural effusion. It provides notification through PACS/workstations to help prioritize and triage cases for review, improving workflow efficiency. The software does not highlight specific image areas but offers case-level alerts to support clinical assessment.

The syngo.via RT Image Suite by Siemens is advanced software that helps clinicians visualize and manipulate 3D and 4D medical images from multiple modalities like CT, MRI, PET, and CBCT. It supports contouring tumors and organs at risk, image registration, and creating simple treatment plans, aiding radiation therapy preparation. The software includes AI-based deep learning for lung lobe segmentation to calculate lung ventilation, improving the accuracy and efficiency of radiation therapy planning.

LiverMultiScan v5 is software that helps clinicians assess liver health by analyzing MRI scans to generate detailed images and quantitative maps of liver tissue properties such as fat content, iron concentration, and T1 relaxation times. It aids doctors in diagnosis by providing automated liver segmentation and measurements that enhance non-invasive liver assessment.

DrAid for Radiology v1 is an AI-based software tool that analyzes adult chest X-rays to identify features indicative of pneumothorax. It helps prioritize cases in the radiology workflow by notifying the system of potentially critical images, assisting clinicians in timely review without providing direct diagnoses or replacing clinical judgment.

Viz RV/LV is a software tool that uses artificial intelligence to automatically measure the size of the right and left ventricles of the heart from CT pulmonary angiogram scans. It provides annotated images and a summary report to assist clinicians in evaluating right ventricular enlargement, potentially aiding diagnosis and treatment decisions.

BriefCase by Aidoc Medical is an AI-powered software that analyzes CTPA images to detect suspected Pulmonary Embolism cases and notifies clinicians via a desktop application to prioritize these potentially critical cases. It works alongside the standard image interpretation process, helping healthcare professionals triage faster and improve patient care without altering original medical images.

MRI Planner is a software tool for radiation oncologists and medical physicists that uses MRI images to help plan radiotherapy treatments. It generates synthetic CT images and automatically outlines certain healthy anatomical structures to assist in treatment planning, particularly for cancers in the brain, head-neck, and pelvic regions. This helps improve the accuracy and efficiency of radiotherapy planning without manually contouring from scratch.

AutoContour RADAC V2 is a software tool that helps radiation treatment planners by automatically outlining anatomical structures in CT and MR images to assist in radiation therapy treatment planning. It uses machine learning models trained on large datasets to generate these contours and allows clinicians to review and modify them before exporting for use in treatment.