510(k) · Cleared
ClearedEchoNext
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pathwai, Inc. · QXO Cardiovascular Machine Learning-Based Notification Software
Cleared on Jun 8, 2026 as substantially equivalent to DEN230003 (Viz. Ai, Inc., 2023) after a 126-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Jun 8, 2026
- Review
- 126 days
- Class
- Class II
- Product code
- QXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230003 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- This deviceK260332 EchoNextPathwai, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| 0 (this device) | K260332 | EchoNext | Pathwai, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QXO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN230003 | Viz HCMSummary page 5…oduct Code: QXO, QYE, SAT, SII, SIJ, SIK Predicate Device Trade / Device Name: Viz HCM (DEN230003) Device Description EchoNext is a software-as-a-medical-device (SaMD) intended to assist clinicians by analyzing standard resti… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate DEN230003.
How does its category compare?
All QXO devicesQXO Cardiovascular Machine Learning-Based Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QXO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QXO
Too few QXO 510(k)s in any year since 2007 to give a median.
Recalls per year · QXO
No recall names QXO since 2007.
Adverse event reports per year · QXO
No MAUDE report names QXO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (160 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260332: EchoNext.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260332
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026