FDA Radiology AI Devices

The Aquilion Serve SP (TSX-307B/1) V1.3 is a multi-slice helical CT scanner that acquires and displays whole-body cross-sectional imaging volumes. It includes an AI-based noise reduction algorithm called AiCE (Advanced Intelligent Clear-IQ Engine) that enhances image quality by reducing noise using deep learning techniques. This helps clinicians obtain clearer diagnostic images for various applications including abdomen, pelvis, lung, cardiac, extremities, head, and inner ear imaging.

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.

BriefCase-Quantification by Aidoc Medical is an AI-driven software designed to analyze non-cardiac-gated, non-contrast CT scans including the heart to detect and categorize coronary artery calcification (CAC). It provides physicians with a four-category risk assessment for coronary artery disease along with preview images of detected calcium, assisting clinical evaluation but not replacing full image review or clinical judgement.

Brainomix 360 Triage Stroke is an AI-powered radiological software that analyzes non-contrast head CT scans to detect suspected large vessel occlusions and intracranial hemorrhages. It helps clinicians by prioritizing and notifying cases that require urgent attention, improving workflow efficiency in the acute stroke setting. The device presents notifications through a web interface or mobile app, but is not intended for primary diagnosis and should be used alongside standard clinical assessments.

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.

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.

Contour ProtégéAI by MIM Software Inc. is a medical imaging software that assists trained medical professionals by automatically creating contours on CT and MR images using machine learning. It helps in radiation therapy by segmenting anatomical structures and specific tissues like the prostate and urethra from imaging data, improving efficiency and accuracy in treatment planning. The software works on multiple platforms and supports cloud or local deployment, allowing users to review and edit automated results for patient management and follow-up.

BriefCase-Triage by Aidoc Medical is an AI-powered software that analyzes CT pulmonary angiography images to detect suspected cases of Central Pulmonary Embolism. It provides notifications and low-quality preview images to assist trained clinicians in prioritizing urgent cases, helping speed up patient care without replacing the standard diagnostic process.

MeVis Liver Suite is a medical image analysis software designed to assist physicians, especially radiologists and surgeons, in evaluating the liver and its vascular anatomy using CT and MR images. It provides tools for manual and AI-based semi-automatic segmentation of abdominal organs, liver lesions, and vascular structures, supporting treatment planning and follow-up assessment for liver-related conditions. The software calculates volumes, visualizes 3D vascular tumor margins, and enables manual spatial registration of images, enhancing clinical workflow without replacing diagnostic workstations.