510(k) K232699
- Device
- Low Ejection Fraction AI-ECG Algorithm
- Applicant
- Anumana, Inc.
- 510(k) number
- K232699
- Product code
- QYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-28
- Date received
- 2023-09-05
- Regulation
- 870.2380
- Classification name
- Reduced Ejection Fraction Machine Learning-Based Notification Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Suzanne Goodman
- Address
- One Main St., Suite 400 East Arcade 4th Floor Cambridge MA US 02142 02142
FDA Registration Numbers#
- 3029762850
- 3027245002
- 3011651230
- 3013200421
Source Documents#
Other 510(k) Records For Product Code QYE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250649 | Bunkerhill ECG-EF | BunkerHill Health | 2025-09-19 |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | 2025-07-28 |
| K250119 | Tempus ECG-Low EF | Tempus AI, Inc. | 2025-07-15 |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | 2024-03-28 |