FDA AI Clearance Tracker/K253801
Cardiovascular · 510(k)
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
Anumana, Inc.
About this listing
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) from Anumana, Inc. appears on the U.S. FDA list of AI-enabled medical devices under submission K253801. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated April 7, 2026. Its primary FDA product code is SHP.
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 Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
- Company
- Anumana, Inc.
- Submission number
- K253801
- Pathway
- 510(k)
- Decision date
- Apr 7, 2026
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- SHP
More from Anumana, Inc.
K260300 · Jun 15, 2026
WatchMate Software
Anumana, Inc.
K252360 · Mar 28, 2026
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc.
K250652 · Jul 28, 2025
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana, Inc.
K232699 · Sep 28, 2023
Low Ejection Fraction AI-ECG Algorithm
Anumana, Inc.
More Cardiovascular AI devices
K260332 · Jun 8, 2026
EchoNext
Pathwai, Inc.
K252859 · May 29, 2026
ZEUS Platform (FG0501US)
iRhythm Technologies, Inc.
DEN250057 · May 22, 2026
PCWP Analysis Software
Cardiosense, Inc.
K252945 · Apr 17, 2026
Novasight Hybrid System
Conavi Medical, Inc.
K252089 · Mar 12, 2026
Tyto Stethoscope (G3)
Tyto Care , Ltd.
K252972 · Feb 20, 2026
CARTO 3 EP Navigation System V8.4
Biosense Webster, Inc.
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.