Anumana, Inc. — FDA PCCPs
Anumana, Inc. holds 4 FDA-authorized PCCPs in this tracker, 4 AI/SaMD. Here is the full list, newest first.
- K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc.2026-04-07AI/SaMDI/O expansion
- K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc.2026-03-28AI/SaMDRetraining
- K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.2025-07-28AI/SaMDModel update
- K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.2023-09-28AI/SaMDUnknown
Other companies
Want the monitoring teardown?
We read the Anumana, Inc. 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.