Device Atlas

EchoNext

Q: When was EchoNext cleared by the FDA?

EchoNext (K260332) received a 510(k) decision of Substantially Equivalent on June 8, 2026, 126 days after the submission was received.

Q: What is the product code of K260332?

The FDA product code is QXO – Cardiovascular Machine Learning-Based Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2380.

FDA 510(k) K260332 · Pathwai, Inc.

Substantially Equivalent

510(k) numberK260332

Submission

Device name: EchoNext
Applicant: Pathwai, Inc.
New York, NY, US
Received: February 2, 2026
Decision date: June 8, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QXO – Cardiovascular Machine Learning-Based Notification Software
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2380
Specialty: Cardiovascular

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…

Questions and answers

When was EchoNext cleared by the FDA?

EchoNext (K260332) received a 510(k) decision of Substantially Equivalent on June 8, 2026, 126 days after the submission was received.

What is the product code of K260332?

The FDA product code is QXO – Cardiovascular Machine Learning-Based Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2380.