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AI/SaMD PCCPs

64 of the 143 FDA-authorized PCCPs in this tracker are AI/SaMD. Here is the full list, newest first.

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Non-AI PCCPs (64)AI hardware PCCPs (15)

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We read the AI/SaMD PCCPs in this list, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.

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Source: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.

This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.