EGG-AF

Primary DI
00860011843603
Brand
EGG-AF
Company
Tempus AI, Inc.
Model
3
Device description
Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG devices from patients 65 years of age and older. The software employs machine learning techniques to analyze ECG recordings and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. The device is designed to extract otherwise unavailable information from ECGs conducted under the standard of care, to help health care providers better identify patients who may be at risk for undiagnosed AF in order to evaluate them for referral of further diagnostic follow up and address the unmet need of reducing the number of undiagnosed AF patients.
Published
2024-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SBQAtrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBQAtrial Fibrillation Risk Prediction Machine Learning-Based Notification SoftwareCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233549000Tempus ECG-AFTempus AI, Inc.2024-06-21SBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011843603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011843603008600118436038600118436030860011843603

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

Contacts#

Phone, Email table
PhoneEmail
800-739-4137support@tempus.com

Regulatory Flags#

DUNS number
080037051
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011843610Tempus ECG-Low EF22025-07-24