Tempus ECG-Low EF
Basic Information
- Brand Name
- Tempus ECG-Low EF
- Primary DI
- 00860011843610
- Version / Model
- 2
- Company Name
- Tempus AI, Inc.
- Labeler DUNS
- 080037051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-24
- Public Version
- 2
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- 24bef610-44f8-4970-bb5e-e8fdd5effdc4
Device Description
Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure. This population includes but is not limited to patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease. Tempus ECG-Low EF only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-Low EF is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | Cardiovascular | 870.2380 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47699 | Cardiopulmonary physiological parameter analysis software, professional-only | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860011843610 | GS1 |
Customer Contacts
- Phone
- 800-739-4137
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250119 | 000 |