Ceribell Seizure Detection Software
Ceribell, Inc. · K241589
FDA-authorized Predetermined Change Control Plan
- Company
- Ceribell, Inc.
- 510(k)/De Novo #
- K241589
- Decision date
- 2025-04-09
- Panel
- Neurology
- Pathway
- 510(k)
- Category
- AI/SaMD
- PCCP type
- Retraining
- Monitoring commitment
- Not stated
What this PCCP covers. Permits model retraining with additional data
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- K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.2025-11-21AI/SaMDRetraining
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We read the PCCP for Ceribell Seizure Detection Software, 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.
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