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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 K243253
Device Name 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
Applicant
Esaote, S.P.A.
Via Enrico Melen, 77
Genoa,  IT 16152
Applicant Contact Piet De Jong
Correspondent
Esaote, S.P.A.
Via Enrico Melen, 77
Genoa,  IT 16152
Correspondent Contact Vanessa Ronconi
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received10/15/2024
Decision Date 06/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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