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Youssef, A., Fronk, D., Grimes, J.N., Cheuy, L. and Larson, D.B. (2024) Beyond the Black Box: Avenues for Transparency in Regulating Radiological AI/ML-Enabled SaMD via the FDA 510(k) Pathway.
https://doi.org/10.1101/2024.07.12.24309602

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