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

Name: FDA 510(k) clearance K253801
Creator: U.S. Food and Drug Administration
Published: 2026-04-07

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.

Clearance details

Applicant: Anumana, Inc.
Product code: Code SHP
Device class: Class 2
Regulation: 21 CFR 870.2380
Advisory panel: Cardiovascular
Date received: 2025-11-28
Decision date: 2026-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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