FDA Radiology AI Devices

QUIBIM Precision Prostate (qp-Prostate) is software designed to assist trained professionals such as radiologists in viewing and analyzing prostate MRI scans. It offers advanced post-processing features to quantify diffusion and perfusion characteristics, helping clinicians better visualize prostate tissue and complete structured reports. This software enables improved image analysis and decision support without performing a direct diagnostic function.

AI Metrics is a software-based medical imaging tool that helps clinicians view, annotate, and analyze images from multiple modalities and time points. It automates workflow steps in assessing diseases and monitoring response to therapy according to standards like RECIST 1.1, supporting clinical interpretations and documentation in radiology and oncology settings. Importantly, it assists but does not replace the physician's diagnosis process.

Revolution Ascend is a computed tomography (CT) scanner designed for head, whole body, cardiac and vascular imaging. It produces detailed cross-sectional images using X-ray data taken from multiple angles. The system incorporates advanced AI-enabled features like deep learning-based auto positioning and machine learning-enabled intelligent protocoling to improve workflow and image acquisition. It aids clinicians in diagnosis, treatment planning, and monitoring.

syngo.via MI Workflows and syngo MBF are software applications by Siemens for advanced medical image processing and analysis. They work with various imaging modalities including PET, SPECT, CT, and MRI to help clinicians view, quantify, and compare images. The software supports disease management in oncology, cardiology, neurology, and organ function and also aids radiotherapy treatment planning.

FastStroke, CT Perfusion 4D is a software package designed to aid clinicians in analyzing and visualizing CT scans, especially for stroke assessment. It processes and displays vascular and perfusion data from CT scans of the head and neck to help identify collateral vessels and perfusion abnormalities, assisting physicians in stroke evaluation and treatment planning.

Caption Guidance is an AI-powered software accessory designed to assist medical professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance to help users obtain standard echocardiographic views, improving image quality and diagnostic accuracy.

HYPER DLR is a software-only device that applies a pre-trained convolutional neural network to reduce noise in fluorodeoxyglucose (FDG) PET images. It improves image quality by distinguishing and removing noise components while preserving image details, aiding radiologists and nuclear medicine physicians in better image interpretation.

Ezra Plexo Software is a medical imaging application designed to help radiologists view, manipulate, and compare 2D and 3D MR images through a web browser. It supports oncological workflows by enabling visualization, evaluation, quantification, and documentation of lesions, facilitating better clinical assessment and decision-making.

AI-Rad Companion Engine is a software platform that supports visualization and post-processing of medical images for diagnostic use, helping clinicians by facilitating measurement, analysis, and data management. It integrates with multiple imaging modalities and PACS systems, providing an interface to add additional AI-driven clinical processing extensions.

uWS-MR is a comprehensive medical imaging software that assists clinicians in viewing, manipulating, and analyzing MR images. It supports numerous advanced applications such as MR cardiac analysis, neuroimaging evaluation, spectroscopy, dynamic imaging, vessel analysis, and fusion of image series. It facilitates better interpretation and quantitative evaluation of various MR studies to aid diagnostic and clinical decision-making.