FDA Radiology AI Devices

syngo.CT CaScoring is a post-processing software that assists physicians in evaluating and documenting calcified coronary artery lesions using CT scans. It calculates detailed calcium scores for the coronary arteries and generates reports to aid in cardiac risk assessment, helping clinicians detect and quantify coronary artery disease.

Deep Learning Image Reconstruction software by GE Healthcare is an AI-powered CT image reconstruction tool that uses a deep neural network to produce high-quality CT images for head, whole body, cardiac, and vascular scans. It improves image noise, contrast detectability, and spatial resolution, helping clinicians obtain clearer images from CT scans for accurate diagnosis and patient care.

Icobrain is an AI software tool that helps clinicians automatically identify, label, and measure brain structures and abnormalities using MRI or CT images. It supports tracking changes in brain volumes over time, aiding diagnosis and monitoring of brain diseases such as dementia or traumatic brain injury.

QyScore Software is an automated medical image processing software that analyzes brain MRI scans to segment and measure brain structures and lesions. It generates an electronic report and overlays segmentations on images, helping clinicians quantify brain volumes compared to a healthy reference population. This assists in assessment and monitoring of brain health in patients aged 20 to 90 years.

NemoScan is an image processing system designed for radiological applications, helping clinicians by enhancing and analyzing medical images to support diagnosis and treatment planning.

Transpara is an AI-powered software designed to assist radiologists in detecting and diagnosing breast cancer from screening mammograms. It highlights suspicious soft tissue lesions and calcifications and provides likelihood scores for cancer presence, helping clinicians make more informed decisions during mammogram interpretation.

PhantomMSK Trauma is a software tool that helps surgeons during orthopedic trauma surgeries by providing precise measurements and image analysis of fluoroscopic images. It assists in the intraoperative positioning of implants relative to bone structures, helping improve surgical accuracy without primary image interpretation.

HealthCXR is a software tool that uses artificial intelligence to analyze adult chest X-ray images for signs of pleural effusion, a condition where fluid accumulates around the lungs. It automatically alerts radiologists by prioritizing critical cases in their worklists, helping them to review urgent scans faster. The software operates alongside the standard care workflow and does not provide a diagnosis on its own, but assists clinicians in managing their caseload more efficiently.

RSI-MRI+ is software designed to assist clinicians by automatically processing diffusion-weighted and anatomical MRI images. It enhances the visibility of restricted diffusion areas, fuses these with anatomical images, and uses AI to segment and quantify the prostate, providing helpful reports. This helps radiologists and urologists more efficiently analyze prostate MRI data.

EchoGo Core is an automated software application that processes echocardiogram images to measure cardiac function parameters such as ejection fraction, global longitudinal strain, and left ventricular volumes. It provides clinicians with quantitative reports to assist in diagnosing heart conditions, improving accuracy and reducing variability compared to manual methods.