ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm

Primary DI
00860013616823
Brand
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm
Company
Anumana, Inc.
Model
1010
Device description
v3.0.0, v3.0.1
Published
2026-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QYEReduced Ejection Fraction Machine Learning-Based Notification Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYEReduced Ejection Fraction Machine Learning-Based Notification SoftwareCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013616823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013616823008600136168238600136168230860013616823

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary physiological parameter analysis software, professional-onlyA software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118190277
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007426469ECG-AI Cardiac Amyloidosis 12-Lead algorithm10402026-04-14
00860013616885ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm10202026-04-14
00860007426445ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm10102024-12-05
00860007426407ECG-AI LEF 12-Lead Algorithm10102024-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011843610Tempus ECG-Low EFTempus AI, Inc.QYE2025-07-24
00850010298146ELEFT (Eko Low Ejection Fraction Tool)Eko Devices, Inc.QYE2025-03-17
00860007426445ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithmAnumana, Inc.QYE2024-12-05
00860007426407ECG-AI LEF 12-Lead AlgorithmAnumana, Inc.QYE2024-01-15