Cardiovascular · 510(k) · 2026
EchoNext
Pathwai, Inc.. Cleared by FDA on 8 June 2026 under submission K260332, product code QXO (cardiovascular machine learning-based notification software). What FDA's record says, in FDA's words.
Device record · K260332
- Device. EchoNextDEVICE
- Company. Pathwai, Inc.COMPANY
- Decision. 8 June 2026, 510(k), substantially equivalent (traditional review); received 2 February 2026DECISION
- Panel. CardiovascularPANEL
- Product code. QXO, Cardiovascular Machine Learning-Based Notification SoftwareCODE
- Regulation. 21 CFR 870.2380, Class IIREG
- Source. FDA database entry · decision document (11 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.
EchoNext is intended to be used in parallel to the standard of care to analyze recordings of 12-lead ECG (electrocardiogram) made on compatible ECG devices. EchoNext is capable of analyzing the ECG, detecting signs associated with structural heart disease (SHD), and allowing the user to view the ECG and analysis results. When evidence of SHD is detected, the device additionally may detect six sub-labels, which are specific forms of SHD. EchoNext is indicated for use on 12-lead ECG recordings collected from patients 18 years of age or older. EchoNext is not intended for use on patients with implanted pacemakers. EchoNext is limited to analysis of ECG data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis. EchoNext identifies patients for further SHD follow-up and is not intended to replace the current standard of care methods for diagnosis of SHD. The results of the device are not intended to rule-out SHD follow-up.
The product code's definition, from FDA's classification record. Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.
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
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QXO. 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 QXO, in Cardiovascular, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.