FDA Radiology AI Devices

AVIEW CAC is a software tool designed for healthcare professionals to analyze non-contrast, non-gated Chest CT scans and quantitatively evaluate calcified plaques in coronary arteries. It automatically calculates the Agatston score, segments and evaluates the coronary arteries, and provides risk stratification based on calcium score, gender, and age. It facilitates access to CT data on various platforms, helping clinicians assess coronary artery disease risk using existing CT images.

SubtleHD (1.x) is an AI-based image processing software designed to enhance MRI images from any body part. It improves image quality by reducing noise and increasing sharpness, helping radiologists obtain clearer images without changing the original scan process. This facilitates improved diagnostic confidence and visualization of anatomical structures.

Ultrasound Workspace (UWS 6.0) is a clinical software package from Philips designed for analyzing and quantifying ultrasound images of cardiovascular, fetal, and abdominal structures. Using AI and machine learning, it supports physicians in diagnosing conditions by automating the measurement of heart functions, valve anatomy, and blood flow dynamics. This helps improve efficiency and accuracy in interpreting ultrasound exams, particularly in adult cardiac applications.

BoneMetrics (US) is an AI-powered software that automatically measures Cobb angles on frontal spine x-rays to assist healthcare professionals in evaluating spinal deformities such as scoliosis. It integrates with existing imaging systems to provide quantitative angle measurements that can support clinical decision-making, improving workflow efficiency and consistency.

TeraRecon Aorta.CT is a software that automatically segments and labels key anatomical landmarks of the aorta from contrast CT Angiography scans. It helps trained medical professionals by providing 3D visualizations and measurements to assist in patient management and procedure planning, without altering the original scan data or providing diagnosis.

Rapid Neuro3D is an AI-powered medical software that processes CT angiography scans to provide 3D and 2D visualizations of the brain's arterial blood vessels. It helps physicians confirm the presence or absence of identified lesions and assists in evaluation and treatment planning by simplifying image interpretation.

Ezra Flash is a software device that improves the quality of MRI images of the head, abdomen, and pelvis by reducing noise using advanced neural network algorithms. It processes images from 1.5T and 3T Siemens and GE MRI scanners, helping clinicians get clearer images to support more accurate diagnoses without additional scanning time.

Ortho AI is a medical software device that helps orthopedic surgeons by using AI to semi-automatically measure lengths, angles, and implant positions on radiographic images. It assists in preoperative and intraoperative planning for hip, knee, and lumbar spine surgeries through digital annotations and measurements, improving surgical planning accuracy and efficiency.

The OrthoNext Platform System is a web-based software that helps healthcare professionals plan orthopedic surgeries and treatments by overlaying product templates on X-ray images and providing measurement and simulation tools. It assists in both preoperative and postoperative planning, enabling clinicians to make informed decisions by digitally visualizing and measuring treatment options.

Saige-Density is a software tool that analyzes digital mammography and breast tomosynthesis images to categorize breast density according to the ACR BI-RADS Atlas 5th Edition. It aids radiologists by providing adjunctive information to help assess breast tissue composition, improving the evaluation process, although it is not a diagnostic aid itself.