FDA Radiology AI Devices

Annalise Enterprise is an artificial intelligence software designed to analyze chest X-ray images to detect several critical findings such as pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fractures. It supports clinicians by prioritizing studies containing these suspected findings to streamline and accelerate patient care workflow, aiding in triage and worklist management.

Rayvolve PTX-PE is an AI-based software tool designed to automatically analyze chest X-ray images for critical findings like pleural effusion and pneumothorax. It helps healthcare professionals prioritize cases by providing study-level notifications for worklist management, thereby improving the efficiency of radiological workflows without replacing clinical decision-making.

BriefCase-Triage by Aidoc Medical, Ltd. is an artificial intelligence software that analyzes CT scans including the ribs to identify suspected acute rib fractures. It alerts clinicians with notification and preview images to help prioritize cases for faster review, aiding workflow triage without altering original images or serving as a diagnostic tool. This helps radiologists address urgent findings more efficiently.

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is an AI-based software tool that analyzes adult chest X-rays to detect critical conditions such as pleural effusion and pneumothorax. It prioritizes cases in the clinical workflow by providing passive notifications in the radiologist's PACS or workstation, helping healthcare professionals manage urgent cases efficiently. The software supports DICOM and common image formats and is intended to assist rather than replace clinical decision-making.

CINA-VCF is an AI-powered software device designed to analyze chest and abdominal CT scans in patients aged 50 and above to identify suspected vertebral compression fractures. It operates alongside standard imaging workflows to prioritize and notify clinicians of potentially positive cases, helping improve triage speed and efficiency without altering original images or serving as a diagnostic tool itself.

VinDr-Mammo is a software tool designed to assist radiologists in prioritizing mammogram exams by flagging those that may contain suspicious findings. It analyzes 2D digital mammograms using artificial intelligence to identify potentially concerning cases and alerts radiologists, enabling more efficient workflow and faster patient care. It does not replace the physician's final diagnosis.

SmartChest is an AI software that analyzes frontal chest X-rays to detect suspected pleural effusion and pneumothorax. It helps radiologists by prioritizing cases with critical findings in their worklists, improving workflow efficiency. The software passively notifies the radiologist without replacing clinical decision-making.

Radify Triage is an AI-powered software that analyzes adult chest X-ray images to detect critical findings like pleural effusion and pneumothorax. It provides a notification within the PACS system to help radiologists prioritize urgent cases, improving workflow efficiency and patient care. It acts as a triage tool to flag suspicious cases but does not replace clinical decision-making.

BraveCX is an AI-based software that analyzes adult chest X-ray images to detect pleural effusion and pneumothorax. It helps radiologists prioritize cases with suspected critical findings by flagging suspicious images in the PACS worklist, enhancing workflow efficiency without providing direct diagnostic decisions.

qXR-PTX-PE is an AI-powered software that assists radiologists by automatically analyzing adult chest X-rays to detect signs of pleural effusion and pneumothorax. It helps prioritize cases by providing case-level outputs within the existing PACS/workstation without altering images or providing direct clinical diagnosis, thereby improving workflow efficiency.