Neurology PCCPs
9 of the 143 FDA-authorized PCCPs are in the Neurology panel, 6 of them AI/SaMD. Here is the full list, newest first.
- K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-05-21AI hardwareCompatibility expansion
- K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.2026-01-11AI hardwareRetraining
- K251936Ceribell Delirium Monitor SystemCeribell, Inc.2025-12-08AI/SaMDRetraining
- K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.2025-11-21AI/SaMDRetraining
- K251519RelieVRx (Pico G3)Appliedvr2025-08-13Non-AIHardware
- K243558Canvas DxCognoa, Inc.2025-04-11AI/SaMDRetraining
- K241589Ceribell Seizure Detection SoftwareCeribell, Inc.2025-04-09AI/SaMDRetraining
- K240408REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc.2024-10-17AI/SaMDRetraining
- K231779REMI AI Discrete Detection ModuleEpitel, Inc.2024-01-03AI/SaMDRetraining
Other panels
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We read the Neurology 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.
Book a callSource: 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.