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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 K253310
Device Name 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
Applicant
Esaote, S.P.A.
Via Enrico Melen 77
Genoa,  IT 16152
Applicant Contact Antonia Perrella
Correspondent
Esaote, S.P.A.
Via Enrico Melen 77
Genoa,  IT 16152
Correspondent Contact Antonia Perrella
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received09/29/2025
Decision Date 11/25/2025
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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