FDA AI Clearance Tracker/K250652
Cardiovascular · 510(k)
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana, Inc.
About this listing
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) from Anumana, Inc. appears on the U.S. FDA list of AI-enabled medical devices under submission K250652. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated July 28, 2025. Its primary FDA product code is QYE.
The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.
- Device
- ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
- Company
- Anumana, Inc.
- Submission number
- K250652
- Pathway
- 510(k)
- Decision date
- Jul 28, 2025
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- QYE
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Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.