FDA 510(k) · Pathwai
K260332: EchoNext (Pathwai, Inc.)
Pathwai, Inc. received FDA 510(k) K260332 for EchoNext, with a decision date of Jun 8, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K260332 |
|---|---|
| Pathway | 510(k) |
| Applicant | Pathwai, Inc. |
| Device name | EchoNext |
| Product code | QXO: Cardiovascular Machine Learning-Based Notification Software |
| Regulation (21 CFR) | 870.2380 |
| Device class | Class 2 |
| Date received | Feb 2, 2026 |
| Decision date | Jun 8, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- DEN230003 Viz HCM (Viz.ai)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QXO is "Cardiovascular Machine Learning-Based Notification Software", class 2, 21 CFR 870.2380. FDA's definition: "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."
Our labels for filtering: claim Other, sensor Unknown. These are heuristics, not FDA fields.