November 17, 2021 — Lunit, a leading medical artificial intelligence (AI) provider, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest X-ray triaging solution, Lunit INSIGHT CXR Triage. With this first FDA clearance, the company is now able to commercially provide the AI solution to medical professional and healthcare institutions in the U.S.
Lunit INSIGHT CXR Triage is a computer-assisted triage and notification software that analyzes chest X-ray images for the presence of pre-specified suspected critical findings. According to the company, the product is designed to triage and prioritize emergent cases such as pleural effusion and pneumothorax immediately after the exam, to have the findings notified to the physicians, thereby reducing the time-to-diagnosis of urgent cases.
"It's with great pleasure that we announce the first FDA clearance of our chest x-ray AI solution," said Brandon Suh, CEO of Lunit. “Lunit INSIGHT CXR Triage can especially show its value in emergency settings where timely workflow is critical, and we look forward to installations in hospitals and medical centers across the U.S.”
The product is trained with over 160,000 chest radiographs with CT images and shows excellent performance of 94~96% sensitivity and 95~99% specificity on pleural effusion and pneumothorax. (ROC AUC=0.9864 and 0.9973 respectively). The high accuracy with instant prioritization of the patient X-rays can optimize workflow and help medical professionals provide timely treatment.
The FDA clearance can also boost the company's plan to accelerate its sales expansion in the US market. As Lunit INSIGHT CXR Triage is best applied with mobile-based X-ray devices that are often used in urgent care settings, the company can maximize current partnerships with global medical device companies like Philips and Fujifilm.
Lunit INSIGHT CXR Triage will be presented at RSNA 2021, scheduled to be held on Nov. 28 to Dec. 2, 2021, in Chicago. Lunit booth will be located at AI Showcase, booth #4545.
For more information: https://www.lunit.io/en
November 11, 2025 
