FDA Radiology AI Devices

ClariCT.AI is an AI-powered software solution that enhances the quality of CT images by reducing noise, especially in low-dose scans. This helps radiologists get clearer images to improve diagnosis while potentially lowering patient radiation exposure. It is compatible with CT images from any manufacturer and integrates seamlessly with medical IT systems.

Us2.v1 is an AI-powered software platform that automatically processes and analyzes transthoracic cardiac ultrasound images to measure key cardiac structural and functional parameters. It helps cardiologists and healthcare providers by producing comprehensive reports to support clinical decision-making for adult patients.

GI Genius is an artificial intelligence-based software device designed to assist endoscopists during colonoscopy. It analyzes live video images from standard white-light endoscopy in real time and highlights abnormal colonic mucosal lesions such as polyps and adenomas to aid detection. By providing visual markers on the video display, it helps clinicians identify lesions that might be missed, improving detection rates and supporting clinical decision making.

Chest-CAD is a computer-assisted detection software that uses machine learning to analyze adult chest X-rays. It identifies and highlights suspicious regions in various categories like cardiac, lungs, bones, and more, assisting physicians with concurrent reading during diagnosis. This helps improve detection accuracy and clinical workflow efficiency.

Oxehealth Vital Signs is a software device that uses optical cameras to noninvasively measure pulse rate and estimated breathing rate from video footage of patients. It facilitates vital sign monitoring in single-occupancy hospital rooms and care environments without physical contact, helping clinicians monitor patients effectively, especially those who do not require critical or continuous monitoring.

Change Healthcare Anatomical AI is a standalone software that uses AI algorithms to analyze CT and MR images, automatically identifying anatomical regions and creating detailed anatomic descriptors. This information helps clinicians and integrated healthcare systems quickly locate and categorize relevant images or studies without altering the original images.

PowerLook Density Assessment V4.0 is a software tool that analyzes synthetic 2D images from digital breast tomosynthesis exams to provide breast density categories using the ACR BI-RADS 5th Edition. This helps radiologists assess breast tissue composition as an adjunctive aid, improving breast cancer screening processes.

HALO is an AI-powered notification software that analyzes brain CT angiograms to detect signs of suspected intracranial Large Vessel Occlusion (LVO). It helps clinicians by promptly notifying appropriate medical specialists to facilitate quicker evaluation and treatment of stroke patients, improving emergency care and patient outcomes.

The MAGNETOM Free.Max is a magnetic resonance imaging (MRI) system that creates detailed cross-sectional images of the internal structures and functions of the head, body, and extremities. It includes advanced hardware and software features to enhance image quality and assist clinicians in diagnosing various conditions by providing clear and accurate images.

RayStation 10.1 is a software platform used to plan, analyze, and administer radiation therapy treatment and medical oncology. It helps clinicians generate and review treatment plans based on imaging data and user input, including advanced features like brachytherapy and ocular proton treatment planning. This system supports improved treatment accuracy and workflow efficiency for radiation oncology professionals.