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I/O expansion PCCPs

14 of the 143 FDA-authorized PCCPs are I/O expansion plans, 5 of them AI/SaMD. Here is the full list, newest first.

Other PCCP types

Unknown PCCPs (46)Retraining PCCPs (41)Compatibility expansion PCCPs (16)Other PCCPs (9)Architecture change PCCPs (7)Panel expansion PCCPs (3)Hardware PCCPs (3)Change management PCCPs (2)Model update PCCPs (2)

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We read the I/O expansion 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.