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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K260589
Device Name ES-Series
Applicant
E-Scopics
235 Rue Léon Foucault
Aix-En-Provence,  FR 13290
Applicant Contact Aurelie Gruener
Correspondent
E-Scopics
235 Rue Léon Foucault
Aix-En-Provence,  FR 13290
Correspondent Contact Aurelie Gruener
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/20/2026
Decision Date 04/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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