FDA.report

510(k) K250652

Device
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Applicant
Anumana, Inc.
510(k) number
K250652
Product code
QYE
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-28
Date received
2025-03-04
Regulation
870.2380
Classification name
Reduced Ejection Fraction Machine Learning-Based Notification Software
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Taylor Gold West
Address
One Main St., Suite 400 East Arcade 4th Floor Cambridge MA US 02142 02142

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code QYE

510(k)DeviceApplicantDecision date
K250649Bunkerhill ECG-EFBunkerHill Health2025-09-19
K250119Tempus ECG-Low EFTempus AI, Inc.2025-07-15
K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc.2024-03-28
K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.2023-09-28