ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is an AI-enabled medical device from Anumana, Inc. that the U.S. FDA cleared through 510(k) K253801 on April 7, 2026. Its lead review panel is Cardiovascular and its primary product code is SHP (Cardiac Amyloidosis Machine Learning-Based Notification Software).
See also FDA-cleared AI cardiovascular devices in 2026, all FDA AI clearances in 2026, top cardiovascular AI devices.
Key facts
| Submission number | K253801 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Anumana, Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | SHP — Cardiac Amyloidosis Machine Learning-Based Notification Software |
| Applicant (openFDA) | Anumana, Inc. |
| Applicant location | Cambridge, MA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2380 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) went through this pathway (K253801).
openFDA lists it as a Class 2 device under 21 CFR 870.2380. Class II devices are moderate risk and are subject to general and special controls.
Product code SHP covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Anumana, Inc. has 5 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.