Cleared Traditional

Low Ejection Fraction AI-ECG Algorithm

K232699 · Anumana, Inc. · Cardiovascular
Sep 2023
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K232699 is an FDA 510(k) clearance for the Low Ejection Fraction AI-ECG Algorithm, a Reduced Ejection Fraction Machine Learning-based Notification Software (Class II — Special Controls, product code QYE), submitted by Anumana, Inc. (Cambridge, US). The FDA issued a Cleared decision on September 28, 2023, 23 days after receiving the submission on September 5, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2380.

Submission Details

510(k) Number K232699 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2023
Decision Date September 28, 2023
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QYE — Reduced Ejection Fraction Machine Learning-based Notification Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2380
Definition Reduced Ejection Fraction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Reduced Ejection Fraction For Further Referral Or Diagnostic Follow-up.