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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cardiovascular Machine Learning-Based Notification Software
510(k) Number K260332
Device Name EchoNext
Applicant
Pathwai, Inc.
189 W 89th St.
Apt. 6e
New York,  NY  10024
Applicant Contact Pierre Elias
Correspondent
Pathwai, Inc.
189 W 89th St.
Apt. 6e
New York,  NY  10024
Correspondent Contact Jeffrey Ruhl
Classification Product Code
QXO  
Subsequent Product Codes
QYE   SAT  
Date Received02/02/2026
Decision Date 06/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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