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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 K253288
Device Name 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Applicant
Esaote, S.p.A.
Via Enrico Melen, 77
Genoa,  IT 16152
Applicant Contact Vanessa Ronconi
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 Received09/29/2025
Decision Date 04/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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