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FDA 510(k)

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

K-Number: K250652 · 2025-07-28

ApplicantAnumana, Inc.
Decision Date2025-07-28
Product CodeQYE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) is a medical device manufactured by Anumana, Inc.. It received FDA 510(k) clearance on 2025-07-28 under approval number K250652. The device is classified under product code QYE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)?

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) is a medical device that received FDA 510(k) clearance on 2025-07-28. It is manufactured by Anumana, Inc.. The 510(k) number is K250652.

When was ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) approved by the FDA?

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) received FDA 510(k) clearance on 2025-07-28, under approval number K250652.

What company makes ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)?

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) is manufactured by Anumana, Inc..

What is the FDA product code for ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)?

The FDA product code for ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) is QYE.

Related Clinical Trials

NCT07108231 Inspiratory Muscle Training in Hospitalized Heart Failure Patients RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT06671015 A Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure RECRUITING NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING NCT06304753 ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction COMPLETED

Related PubMed Literature

PMID: 40714034 Relationship between industry payments to physicians and prescription patterns for PCSK9is, ARNis and DOACs: A report from the NCDR PINNACLE registry. American heart journal (2026)

Other Devices by Anumana, Inc.

K233160NeuTrace EP Mapping System v.2.1 K232699Low Ejection Fraction AI-ECG Algorithm K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

Related Devices (Code: QYE)

K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc. K250649Bunkerhill ECG-EFBunkerHill Health K250119Tempus ECG-Low EFTempus AI, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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