Low Ejection Fraction AI-ECG Algorithm
FDA 510(k) K232699 · Anumana, Inc.
510(k) numberK232699
Submission
- Device name
- Low Ejection Fraction AI-ECG Algorithm
- Applicant
- Anumana, Inc.
Cambridge, MA, US - Received
- September 5, 2023
- Decision date
- September 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYE – Reduced Ejection Fraction Machine Learning-Based Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2380
- Specialty
- Cardiovascular
Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up.
Other 510(k)s with product code QYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250649 | Bunkerhill ECG-EFQYE · Traditional | BunkerHill Health | 09/19/2025SE |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)QYE · Traditional | Anumana, Inc. | 07/28/2025SE |
| K250119 | Tempus ECG-Low EFQYE · Traditional | Tempus AI, Inc. | 07/15/2025SE |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT)QYE · Traditional | Eko Health, Inc. | 03/28/2024SE |
More from Eko Health, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260300 | WatchMate SoftwareQIH · Traditional | 06/15/2026SE |
| K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)SHP · Traditional | 04/07/2026SE |
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)SAT · Traditional | 03/28/2026SE |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)QYE · Traditional | 07/28/2025SE |
| K233160 | NeuTrace EP Mapping System v.2.1DQK · Traditional | 11/25/2023SE |
Questions and answers
When was Low Ejection Fraction AI-ECG Algorithm cleared by the FDA?
Low Ejection Fraction AI-ECG Algorithm (K232699) received a 510(k) decision of Substantially Equivalent on September 28, 2023, 23 days after the submission was received.
What is the product code of K232699?
The FDA product code is QYE – Reduced Ejection Fraction Machine Learning-Based Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2380.