Cardiovascular · 510(k) · 2025
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana, Inc.. Cleared by FDA on 28 July 2025 under submission K250652, product code QYE (reduced ejection fraction machine learning-based notification software). What FDA's record says, in FDA's words.
Device record · K250652
- Device. ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)DEVICE
- Company. Anumana, Inc.COMPANY
- Decision. 28 July 2025, 510(k), substantially equivalent (traditional review); received 4 March 2025DECISION
- Panel. CardiovascularPANEL
- Product code. QYE, Reduced Ejection Fraction Machine Learning-Based Notification SoftwareCODE
- Regulation. 21 CFR 870.2380, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Please type in the marketing application/submission number, if it is known. This K250652 ? textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? ECG-Al Low Ejection Fraction (LEF) 12-Lead algorithm Please provide your Indications for Use below. ? The ECG-Al LEF 12-Lead algorithm is software intended to aid in earlier detection of Left Ventricular Ejection Fraction (L VEF) less than or equal to 40% in adults at risk for heart failure. This population includes, but is not limited to: • patients with cardiomyopathies • patients who are post-myocardial infarction • patients with aortic stenosis • patients with chronic atrial fibrillation • patients receiving pharmaceutical therapies that are cardiotoxic, and • postpartum women. The ECG-Al LEF 12-Lead algorithm is not intended to be a stand-alone diagnostic device for cardiac conditions, should not be used for monitoring of patients, and should not be used on ECGs with a paced rhythm. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. Additionally, if the patient is at high risk for the cardiac condition, a negative result should not rule out further non-invasive evaluation. The ECG-Al LEF 12-Lead Aloorithm should be applied iointlv with clinician iudqment. Please select the types of uses (select one or both, as � Prescription Use (Part 21 CFR 801 […]
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsprescription use
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QYE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QYE, in Cardiovascular, from Anumana, Inc., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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