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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 K191007
Device Name Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
Applicant
Supersonic Imagine
Les Jardins De La Duranne - Bat E&F - 510 Rue Rene Descartes
Aix-En-Provence Cedex,  FR 13857
Applicant Contact Jacques Souquet
Correspondent
Supersonic Imagine
Les Jardins De La Duranne - Bat E&F - 510 Rue Rene Descartes
Aix-En-Provence Cedex,  FR 13857
Correspondent Contact Jacques Souquet
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/16/2019
Decision Date 10/25/2019
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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