ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
FDA 510(k) K253801 · Anumana, Inc.
510(k) numberK253801
Submission
- Device name
- ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
- Applicant
- Anumana, Inc.
Cambridge, MA, US - Received
- November 28, 2025
- Decision date
- April 7, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SHP – Cardiac Amyloidosis Machine Learning-Based Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2380
- Specialty
- Cardiovascular
Cardiac Amyloidosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac amyloidosis for further referral or diagnostic follow-up.
More from Anumana, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260300 | WatchMate SoftwareQIH · Traditional | 06/15/2026SE |
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)SAT · Traditional | 03/28/2026SE |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)QYE · Traditional | 07/28/2025SE |
| K233160 | NeuTrace EP Mapping System v.2.1DQK · Traditional | 11/25/2023SE |
| K232699 | Low Ejection Fraction AI-ECG AlgorithmQYE · Traditional | 09/28/2023SE |
Questions and answers
When was ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) cleared by the FDA?
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) (K253801) received a 510(k) decision of Substantially Equivalent on April 7, 2026, 130 days after the submission was received.
What is the product code of K253801?
The FDA product code is SHP – Cardiac Amyloidosis Machine Learning-Based Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2380.