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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 the device name listed in this FDA 510(k) record. The listed applicant is Anumana, Inc.. It received FDA 510(k) clearance on 2025-07-28 under 510(k) 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. The listed applicant is Anumana, Inc.. The 510(k) number is K250652.

When did ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) receive FDA 510(k) clearance?

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

Who is the listed applicant for ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)?

The FDA 510(k) record lists Anumana, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07270692Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial IntelligenceSUSPENDEDNCT07087613Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECGRECRUITINGNCT06011252Pacing Characteristics of a Conventional BipolarACTIVE_NOT_RECRUITINGNCT07775976Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care PathwaysENROLLING_BY_INVITATIONNCT05230732Neuromodulation of Inflammation and Endothelial FunctionRECRUITINGNCT07108231Inspiratory Muscle Training in Hospitalized Heart Failure PatientsRECRUITING

Other records listing Anumana, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260300WatchMate SoftwareK253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)K233160NeuTrace EP Mapping System v.2.1K232699Low Ejection Fraction AI-ECG Algorithm

Related Devices (Code: QYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250649Bunkerhill ECG-EFBunkerHill HealthK250119Tempus ECG-Low EFTempus AI, Inc.K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc.K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.

Official Source

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

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