# K260332: EchoNext

- Pathway: 510(k) (Traditional)
- Applicant: Pathwai, Inc.
- Decided: Jun 8, 2026 after 126 days
- Product code: QXO (Cardiovascular Machine Learning-Based Notification Software)
- Device class: 2
- Regulation: 21 CFR 870.2380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230003 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230003: Viz HCM, Viz. Ai, Inc. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K260332
Methodology: https://510kreport.com/methodology