Data / Medical devices / Reduced Ejection Fraction Machine Learning-Based Notification Software
Reduced Ejection Fraction Machine Learning-Based Notification Software (QYE): 5 FDA-registered makers in 1 country
5 establishments in 1 country are registered with the FDA to make Reduced Ejection Fraction Machine Learning-Based Notification Software (product code QYE, Class 2, 21 CFR 870.2380). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on September 30, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QYE
- Device class
- 2
- Regulation
- 870.2380
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
Makers of Reduced Ejection Fraction Machine Learning-Based Notification Software
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Anumana Inc. | Cambridge, MA, United States | Manufacturer | 2 | July 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bunkerhill Health | San Francisco, CA, United States | Manufacturer | 1 | September 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Eko Health, Inc. | Emeryville, CA, United States | Manufacturer | 1 | March 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| TEMPUS AI, Inc. | Chicago, IL, United States | Manufacturer | 1 | July 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Pathwai, Inc | New York, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.