FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

Annalise Enterprise CXR Triage Trauma is an AI-based software tool designed to assist clinicians by analyzing adult chest X-ray images to detect features suggestive of vertebral compression fractures. It integrates with hospital image and order management systems to prioritize cases with potential fractures, facilitating timely review in clinical workflows such as Bone Health and Fracture Liaison Service programs. The device supports clinicians in identifying urgent cases but does not replace clinical decision-making.

FDA #
K222268
Product Code
QFM

Annalise Enterprise CXR Triage Trauma is an artificial intelligence-based software that assists clinicians by automatically analyzing adult chest X-rays to identify signs of pleural effusion and pneumoperitoneum. It integrates with hospital imaging systems to prioritize urgent cases in the clinical workflow, helping healthcare providers quickly identify critical findings and streamline patient care.

FDA #
K222179
Product Code
QFM

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.

FDA #
K213941
Product Code
QFM
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