FDA AI Clearance Tracker/K252360
Cardiovascular · 510(k)
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc.
About this listing
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) from Anumana, Inc. appears on the U.S. FDA list of AI-enabled medical devices under submission K252360. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated March 28, 2026. Its primary FDA product code is SAT.
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 Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
- Company
- Anumana, Inc.
- Submission number
- K252360
- Pathway
- 510(k)
- Decision date
- Mar 28, 2026
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- SAT
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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.