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# Lunit AI Breast Cancer Detector Cleared
- URL: https://www.fdaweb.com/lunit-ai-breast-cancer-detector-cleared/
- Published: 2021-11-18T12:00:00.000Z
- Updated: 2026-09-14T17:22:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150605

FDA has cleared a Lunit 510(k) for its Insight MMG, an artificial intelligence (AI) application for breast cancer detection. The AI software for breast cancer joins the the company’s AI solutions for chest x-ray and mammography. Insight MMG is a radiology product which analyzes mammography images with high accuracy, Lunit says, providing a location of suspicious lesions and an abnormality score that reflects the AI’s confidence of the existence of detected lesions. “The product is trained with a large-scale data of more than 240,000 mammography cases that include up to 50,000 breast cancer cases, and is known to show excellent performance in finding breast cancer at an earlier stage,” the company says.