K253801
- 510(k) number
- K253801
- Device name
- ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
- Applicant
- Anumana, Inc. MA · US
- Product code
- SHP — Cardiac Amyloidosis Machine Learning-Based Notificat
- Decision date
- 2026-04-07
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253801.pdf
Official FDA record: K253801
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.