FDA Radiology AI Devices

Ceevra Reveal 3+ is a software medical imaging system that processes CT and MRI scans to generate detailed three-dimensional images. It uses machine learning algorithms to assist clinicians in segmenting and visualizing normal anatomy to support preoperative surgical planning and intraoperative display. This helps healthcare professionals better review, analyze, and plan treatment by interacting with 3D images on computers, mobile devices, or VR headsets.

Syngo Carbon Clinicals is a software package that provides advanced visualization tools to help healthcare professionals prepare, measure, and analyze medical images from modalities such as CT and MRI. It supports manipulation and communication of clinical data, enabling qualitative and quantitative assessment to assist in diagnosis and treatment planning.

syngo.via MI Workflows, including Scenium and syngo MBF, is software that helps healthcare professionals analyze medical images from multiple modalities such as PET, SPECT, CT, and MR. It aids disease management in oncology, cardiology, neurology, and organ function by providing tools for image viewing, quantification, comparison, and radiotherapy planning. The software integrates advanced AI algorithms for automating organ segmentation and supports new workflows such as tau quantification in brain imaging, thus improving diagnostic and treatment planning efficiency.

AI Platform (AIP001) by Exo Inc is a software tool designed to help medical professionals assess ultrasound images of the heart and lungs in adult patients. It uses AI to detect and measure features of these images, aiding in quantification and reporting of important clinical parameters such as ejection fraction and lung artifacts, thus supporting diagnosis and treatment decisions in a clinical setting.

Axial3D Insight is a cloud-based image segmentation and 3D modeling service that converts medical imaging data into digital files or 3D printed physical models. These outputs assist clinicians in treatment planning and diagnosis for trauma, orthopedic, maxillofacial, and cardiovascular conditions, improving clinical decision-making.

Clarius Bladder AI is a software application integrated into the Clarius Ultrasound Scanner system that uses artificial intelligence to assist healthcare professionals in semi-automatically measuring bladder volume using ultrasound images. It automates bladder detection and measurement in both sagittal and transverse views but allows users to manually adjust results, facilitating efficient and accurate bladder volume assessment in adult patients.

BriefCase-Quantification is an AI-powered software that automatically measures brain midline shift in non-contrast head CT scans, assisting medical specialists by automating a typically manual measurement process. It provides quantitative analysis and comparative reports over time to help clinicians monitor patients, without altering original images or serving as a standalone diagnostic tool.

BriefCase-Quantification is an AI-powered radiological image management and processing software that analyzes contrast-enhanced CT images to measure the maximum axial diameter of the abdominal aorta. It assists trained medical specialists by providing preliminary measurements to help evaluate normal and aneurysmal abdominal aortas. The tool outputs annotated preview images, which serve as unofficial measurements to aid clinical review, with final decisions left to radiologists.

aprevo® Digital Segmentation is a software tool designed for trained medical personnel to process medical images of the spine, specifically the lumbar area. It uses AI algorithms to automatically segment the spine from DICOM images and generates a 3D model, aiding in clinical planning or design tasks related to spine anatomy.

AI-Rad Companion Brain MR is a software tool that helps clinicians by automatically analyzing MRI brain images. It segments and measures brain structures and white matter hyperintensities, compares these measurements with healthy reference data, and visually presents the results. This assists in evaluating brain changes over time, improving diagnostic workflow and patient monitoring in neurological conditions.