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Top Imaging Technology News News

Lunit Submits 510(k) Application for Image-Based Breast Cancer Risk Prediction Model

Artificial Intelligence · Maryland

Lunit Submits 510(k) Application for Image-Based Breast Cancer Risk Prediction Model

Submission marks a key regulatory milestone toward bringing SEER-calibrated, imaging-based risk assessment to U.S. screening programs SEOUL, South Korea, Dec. 8, 2025 /PRNewswire/ — Lunit (KRX:328130), a leading provider of AI for cancer diagnostics and precision oncology, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) […]See the Story

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