FDA AI Clearance Tracker/K232699
Cardiovascular · 510(k)
Low Ejection Fraction AI-ECG Algorithm
Anumana, Inc.
About this listing
Low Ejection Fraction AI-ECG Algorithm from Anumana, Inc. appears on the U.S. FDA list of AI-enabled medical devices under submission K232699. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated September 28, 2023. 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
- Low Ejection Fraction AI-ECG Algorithm
- Company
- Anumana, Inc.
- Submission number
- K232699
- Pathway
- 510(k)
- Decision date
- Sep 28, 2023
- 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.