FDA.reportPublic FDA data

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

Primary DI
00860007426445
Brand
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm
Company
Anumana, Inc.
Model
1010
Device description
v2.3.0v2.5.0
Published
2024-12-05
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232699000Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.2023-09-28QYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007426407PreviousGS10
00860007426445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007426407008600074264078600074264070860007426407
00860007426445008600074264458600074264450860007426445

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology processing softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation and/or screening of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] or screen for specific conditions (e.g., low ejection fraction). It might include artificial intelligence (AI) and 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
00860013616823ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm10102026-03-20
00860007426407ECG-AI LEF 12-Lead Algorithm10102024-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013616823ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithmAnumana, Inc.QYE2026-03-20
00860011843610Tempus ECG-Low EFTempus AI, Inc.QYE2025-07-24
00850010298146ELEFT (Eko Low Ejection Fraction Tool)Eko Devices, Inc.QYE2025-03-17
00860007426407ECG-AI LEF 12-Lead AlgorithmAnumana, Inc.QYE2024-01-15