ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc. · K252360
FDA-authorized Predetermined Change Control Plan
- Company
- Anumana, Inc.
- 510(k)/De Novo #
- K252360
- Decision date
- 2026-03-28
- Panel
- Cardiovascular
- 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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- K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc.2026-04-07AI/SaMDI/O expansion
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Want the monitoring teardown?
We read the PCCP for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020), 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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