510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260332Substantially Equivalent

EchoNext

Pathwai, Inc, New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260332 is the FDA 510(k) clearance record for EchoNext, a class II device, cleared for Pathwai, Inc. on under FDA product code QXO (Cardiovascular Machine Learning-Based Notification Software). FDA's definition for product code QXO reads: "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...". FDA records list one 510(k) clearance for Pathwai, Inc. As of , FDA records show no recalls naming K260332.

Clearance record

Decision date
Received
(126 days to decision)
Product code
QXO Cardiovascular Machine Learning-Based Notification Software
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Applicant
Pathwai, Inc. 189 W 89th St., New York NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QXO

Trailing 12 months
1 clearance under product code QXO in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QXO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260