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Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan

FDA-2026-N-6535-0001Rule
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Title
Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
Posted
Jun 17, 2026
Comment period
Jun 17, 2026 – ?
FR Doc
2026-12166
CFR
21 CFR Part 892
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