K250652
- 510(k) number
- K250652
- Device name
- ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
- Applicant
- Anumana, Inc. MA · US
- Product code
- QYE — Reduced Ejection Fraction Machine Learning-Based Not
- Decision date
- 2025-07-28
- Date received
- 2025-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250652.pdf
Official FDA record: K250652
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.