FDA Radiology AI Devices

Contour ProtégéAI by MIM Software Inc. is an AI-powered software tool that helps trained medical professionals automatically create contours of anatomical structures on CT and MRI scans. The software uses machine-learning algorithms to segment normal organs and tissues, aiding in quantitative analysis and radiation therapy planning. It is intended to improve workflow efficiency and treatment accuracy by automating tedious contouring tasks.

syngo.CT Brain Hemorrhage is an AI-driven software that assists radiologists by analyzing non-contrast head CT scans to prioritize cases suspicious for acute intracranial hemorrhage. It flags findings to improve workflow efficiency by enabling faster review of urgent cases but is not intended for standalone diagnosis.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 by Canon Medical Systems Corporation, is a high-quality diagnostic ultrasound system that provides detailed visualization of structures and dynamic processes in the human body. It supports multiple ultrasound modes and is suitable for use in hospitals and clinical settings, aiding clinicians in diagnosing conditions across areas including fetal, abdominal, cardiac, musculoskeletal, vascular, breast, and more.

SIGNA Hero is a whole body 3.0 Tesla MRI scanner from GE Healthcare that supports high resolution images with a high signal-to-noise ratio and short scan times. It produces detailed images of structures and functions throughout the body to aid physicians in diagnosis by providing axial, sagittal, coronal and oblique images, along with spectroscopic and dynamic imaging capabilities.

syngo.CT Extended Functionality is a software suite from Siemens that provides advanced visualization tools for CT and possibly MRI medical images. It helps technicians and physicians perform qualitative and quantitative measurements, facilitates advanced clinical evaluations using various extensions, and supports processing to aid in diagnosis.

The Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that automatically analyzes previously acquired cardiac ultrasound images to estimate the left ventricular ejection fraction. This helps clinicians assess heart function more efficiently and accurately by providing automated measurements, confidence metrics, and video clip visualizations within compatible ultrasound or PACS systems.

Follicle Clarity is a cloud-based AI software that helps clinicians by automatically detecting and measuring the number and size of ovarian follicles from transvaginal ultrasound images. It provides graphical and tabular summaries of these measurements to assist in fertility monitoring and related clinical decisions.

SIGNA Prime is a whole body magnetic resonance imaging (MRI) scanner that supports high resolution and fast scan times. It produces detailed images and spectroscopic data of various body regions, helping clinicians diagnose a wide range of conditions by showing the spatial distribution and molecular environment of tissues.

Precise Image is an AI-powered reconstruction software for computed tomography (CT) systems developed by Philips. It produces high-quality images with lower radiation dose and noise, improving the detectability of low contrast features. This helps clinicians obtain clearer diagnostic images from CT scans of the head, body, and vascular regions, enhancing patient safety by reducing radiation exposure while maintaining image quality.

Eclipse II with Smart Noise Cancellation is a software module integrated within the Carestream ImageView application that enhances digital radiography images by reducing noise using a Convolutional Neural Network. It supports various Carestream digital radiography detectors. This technology allows for up to 50% dose reduction in certain detector types without sacrificing image quality, helping clinicians obtain clearer x-ray images at lower radiation doses, thus improving patient safety and diagnostic confidence.