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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 K191023
Device Name Dolphin/IQ, Dolphin/4D and Dolphin/MAX
Applicant
Viasonix , Ltd.
10 Hamelacha St.
Ra'Anana,  IL 4366105
Applicant Contact Shlomi Deler
Correspondent
Viasonix , Ltd.
10 Hamelacha St.
Ra'Anana,  IL 4366105
Correspondent Contact Shlomi Deler
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
ITX  
Date Received04/17/2019
Decision Date 05/16/2019
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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