Devices · Pathwai, Inc.

EchoNext

Pathwai, Inc. is listed for EchoNext (K260332). The FDA list gives June 8, 2026 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QXO as “Cardiovascular Machine Learning-Based Notification Software”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260332

Official FDA database record

Date of final decision

June 8, 2026

Company on the FDA list

Pathwai, Inc.

Lead panel

Cardiovascular

Primary product code

QXO

openFDA device name for the code

Cardiovascular Machine Learning-Based Notification Software

Device class

2

Regulation number

870.2380

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary