FDA Radiology AI Devices

MRCAT Head & Neck is a software tool integrated into Philips MR systems that automatically processes MRI data to create synthetic CT-like images for radiation therapy treatment planning in patients with soft tissue tumors in the head and neck region. It helps clinicians accurately estimate radiation dose distributions without needing a separate CT scan, improving planning precision and patient care.

The EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is an AI-powered software that automatically measures the cardiothoracic ratio from chest X-ray images in the posterior-anterior view. It helps physicians by automatically calculating a key heart size measurement, supporting clinical assessments in hospitals and clinics for adult patients.

DEEPVESSEL FFR is a clinical software tool that uses deep learning to analyze previously acquired coronary CT angiography (CTA) images. It generates three-dimensional models of coronary artery trees and estimates fractional flow reserve (FFR) values to help clinicians assess the functional severity of coronary artery disease. It supports doctors by providing additional insight beyond anatomical imaging, using AI-based physiological simulation to improve diagnosis and treatment planning for heart vessel conditions.

The MAGNETOM Avanto Fit is a 1.5 Tesla magnetic resonance imaging (MRI) system that produces detailed images of the head, body, and extremities. It helps clinicians visualize internal structures and functions non-invasively, potentially including functional information, and can be used during interventional procedures. The device incorporates advanced hardware and software features to enhance image quality and operational efficiency.

The Aplio a550, a450, and a Diagnostic Ultrasound Systems from Canon Medical Systems Corporation provide high-quality ultrasound images in various modes including 2D, Doppler, Color Doppler, Elastography, and 3D/4D imaging. These systems support advanced features enhanced by artificial intelligence and machine learning to assist clinicians in diagnostics across multiple clinical applications such as fetal, abdominal, cardiac, vascular, musculoskeletal, and more.

BriefCase is an AI-powered software that analyzes head CT Angio (CTA) images to assist clinicians by flagging suspected Brain Aneurysm cases above 5 mm, helping prioritize urgent cases and improving workflow efficiency. It provides notifications and preview images but is not intended for primary diagnosis, supporting clinicians to review images faster and potentially reduce time to treatment.

Customize is a software tool designed to assist physicians in planning shoulder arthroplasties by visualizing, modifying, and validating 3D models generated from CT scans. It helps communicate treatment options, segments CT data, and manages cases and timelines, aiding clinicians in surgical preparation and decision-making.

Arterys MICA is a cloud-based medical imaging software that helps healthcare professionals view, process, and analyze medical images from CT and MRI scans. It includes AI modules that assist in cardiac and oncology evaluations by automating image quantification and lesion assessments, supporting clinicians in their diagnostic workflows.

BriefCase is a software device that uses artificial intelligence to analyze chest X-ray images for signs of pneumothorax. It notifies trained medical specialists of suspected positive cases via a desktop app to help prioritize patient care. The software works alongside standard clinical workflows without altering the original images or diagnostic process.

CardIQ Suite by GE Medical Systems is a non-invasive software tool designed to analyze 2D and 3D cardiac CT images, helping clinicians visualize and measure cardiovascular anatomy, including vessels and chamber mobility. It uses advanced AI algorithms for automatic calcium scoring and labeling of calcified plaques, aiding in diagnosis and treatment planning of cardiovascular diseases like coronary artery disease. The software also facilitates tracking calcium progression and supports clinicians with integrated workflows for reviewing coronary CT angiography data effectively.