FDA Radiology AI Devices

ClearRead Xray Pneumothorax is an AI-powered software tool designed to analyze adult chest X-rays and identify signs of pneumothorax larger than 5 mm. It functions as a triage system that notifies radiologists about suspected urgent cases, helping prioritize the review workflow but not replacing diagnostic interpretation.

Annalise Enterprise CXR Triage Pneumothorax is a software tool that uses artificial intelligence to analyze adult chest x-rays for signs of pneumothorax and tension pneumothorax. It assists trained clinicians by automatically prioritizing and triaging cases in their worklist, enabling faster attention to urgent findings. The device integrates with hospital imaging systems and helps optimize workflow without replacing clinical judgment.

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 UNiD Spine Analyzer is a web-based software tool that helps surgeons and healthcare providers view and measure spine-related medical images, plan surgical procedures, and simulate surgical strategies. It incorporates machine learning predictive models to assist in preoperative planning and includes a database of implant templates to aid in selecting and placing surgical implants. The software enhances clinical decision-making by providing quantitative radiographic parameters and predictive outputs for spine surgery planning.

HealthPPT is an AI-powered software tool that helps radiologists by automatically detecting signs of pneumoperitoneum in adult frontal chest X-rays. It prioritizes urgent cases by notifying the radiology workstation with a low-resolution preview image, enabling faster review of potentially critical findings. The device works alongside standard workflows without altering original images and does not itself diagnose the condition, but aids clinical assessment by highlighting suspicious cases for prompt review.

Lunit INSIGHT CXR Triage is an AI-based software tool designed to analyze adult chest X-ray images and identify potentially critical lung conditions such as pleural effusion and pneumothorax. It flags suspicious cases in the radiology workflow, enabling radiologists to prioritize urgent cases more efficiently without altering the standard reading queue. It operates as a supportive notification system and is not intended for standalone clinical decision making.

StrokeSENS LVO is software that uses AI to analyze CT angiograms of the head to identify suspected large vessel occlusions, which can cause strokes. It assists healthcare providers by flagging potential LVO cases and sending notifications to specialists in near real-time, helping prioritize urgent cases and improve workflow efficiency. The software does not alter the original images and is intended to be used alongside existing diagnostic workflows.

InferRead CT Stroke.AI is an AI-powered software that helps hospitals and radiologists prioritize head CT scans by flagging suspected intracranial hemorrhage cases. It analyzes CT images using a deep learning algorithm and highlights potential emergency cases on a worklist, assisting clinicians in faster triage. The software operates alongside standard radiology workflows without altering images or removing cases, improving efficiency in detecting brain hemorrhages.

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.

CINA CHEST is an AI-powered software that analyzes chest and thoraco-abdominal CT angiography scans to detect signs of pulmonary embolism and aortic dissection. It helps radiologists prioritize cases by flagging suspected positive findings through notifications, thereby improving workflow efficiency and timely patient care. The tool works alongside standard image interpretation without altering original images and is not intended for diagnosis alone but as an aid for faster triage.