ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
FDA 510(k) clearance K250652 · decided 2025-07-28
Clearance details
- K-number
- K250652
- Device name
- ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
- Applicant
- Anumana, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-04
- Decision date
- 2025-07-28
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- QYE
- Device class
- 2
- Regulation number
- 870.2380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Bunkerhill ECG-EF (K250649) | BunkerHill Health | 2025-09-19 |
| Tempus ECG-Low EF (K250119) | Tempus AI, Inc. | 2025-07-15 |
| Eko Low Ejection Fraction Tool (ELEFT) (K233409) | Eko Health, Inc. | 2024-03-28 |
| Low Ejection Fraction AI-ECG Algorithm (K232699) | Anumana, Inc. | 2023-09-28 |
Recalls involving this device
No recalls on record reference this clearance.