FDA Radiology AI Devices

BriefCase is an AI-powered software that helps radiologists prioritize cervical spine CT scans by flagging possible fractures. It runs alongside standard image interpretation, notifying clinicians quickly about suspected cases to enable faster patient management, but it is not used for final diagnosis. This helps improve workflow efficiency and timely attention to urgent cases.

SurgicalAR is a software platform that allows clinicians to view and manipulate medical images in both traditional 2D and advanced 3D formats, including augmented reality via head-mounted displays. It aids surgical planning and medical image review by providing tools such as image manipulation, measurements, and 3D visualization of CT and MR images. This enhances the understanding of complex anatomical structures to improve clinical decision making.

HealthPNX by Zebra Medical Vision Ltd. is an AI-powered software that analyzes chest X-rays to identify suspected pneumothorax cases. It helps radiologists prioritize urgent cases by providing passive notifications on their PACS worklist, reducing triage time and potentially improving patient care efficiency. It does not modify images or provide diagnostic decisions independently but supports clinical assessment workflows.

The Lung Vision System is a medical imaging tool designed to assist clinicians by processing radiological images of the lungs. It helps improve visualization and analysis, aiding in the detection and diagnosis of lung-related conditions.

BriefCase by Aidoc Medical, Ltd. is an AI-based radiology triage and notification software designed to assist radiologists by automatically analyzing head CT and chest CT pulmonary angiogram (CTPA) images. It detects suspected cases of Intracranial Hemorrhage and Pulmonary Embolism, providing timely notifications and compressed preview images to prioritize urgent cases. This facilitates faster review and potentially improves patient outcomes by allowing earlier intervention, while not replacing standard diagnostic processes.

Deep Learning Image Reconstruction by GE Medical Systems is a software option for CT scanners that uses a dedicated deep neural network to generate high-quality cross-sectional images of the head and whole body from X-ray transmission data. It improves image quality while maintaining noise performance and spatial resolution, supporting routine clinical workflows for head, whole body, cardiac, and vascular CT scans across all ages.

Bone VCAR is a software tool designed to assist clinicians in reviewing CT images that include the spine. It uses deep learning to automatically label vertebrae and provides optimized display settings to improve visualization and reporting efficiency across multiple care areas such as trauma and oncology.

SIS Software version 3.3.0 is a medical imaging application that assists clinicians, including surgeons and neurologists, by enhancing and visualizing brain MRI images, specifically the subthalamic nucleus (STN). It uses AI and image processing techniques to create 3D models and supports image fusion and co-registration between MRI and CT scans to guide stereotactic surgical procedures more accurately.

cmTriage is a software tool that uses artificial intelligence to analyze 2D digital mammograms and flags suspicious cases to help radiologists prioritize which exams to review first. It integrates with the Picture Archiving and Communication System (PACS) worklist but does not alter images or provide diagnostic results. cmTriage aims to improve the efficiency of breast cancer screening workflows by identifying potentially abnormal cases for quicker attention.

AI Rad Companion (Engine) by Siemens Medical Solutions is a software platform designed to assist technicians and physicians in viewing, processing, and analyzing medical images from multiple modalities. It supports integration with PACS systems and allows external AI-based post-processing extensions, improving clinical image analysis and workflow.