DeviceClearance

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)— 510(k) K253801

Substantially Equivalent

Anumana, Inc.

FDA 510(k) clearance K253801 for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040), Substantially Equivalent on 2026-04-07. Applicant: Anumana, Inc.. Device class: 2.

Summary

Anumana's ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is filed under product code SHP (Cardiac Amyloidosis Machine Learning-Based Notification Software).

Class II, 21 CFR 870.2380. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).

Anumana filed from Cambridge, Massachusetts. The record shows 130 calendar days from receipt to decision (November 28, 2025 to April 7, 2026).

Clearance details

Applicant
Anumana, Inc.
Product code
Product code SHP
Device class
Class 2
Regulation
21 CFR 870.2380
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cambridge, MA, US
Download summary PDFView on FDA.gov ↗

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