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De Novo Classification Order DEN240047: Clairity Breast (FDA, May 2025)

FDA

De Novo Classification Order DEN240047: Clairity Breast (FDA, May 2025)

FDA De Novo order for Clairity Breast, AI that predicts five-year breast cancer risk from a mammogram.

May 1, 2025

Published

FDA

Source

Topic

https://cdn.prod.website-files.com/5f10960649ee0832d2b92042/68b891ad7031638163b55e2e_DEN240047%20-%20Clarity%20-%20Classification%20Order.pdf

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