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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 K222191
Device Name Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
Applicant
Supersonic Imagine
Zac De L`Enfant 135 Rue Emilien Gautier
Aix En Provence,  FR 13290
Applicant Contact Shalyna Bansropun
Correspondent
Supersonic Imagine
Zac De L`Enfant 135 Rue Emilien Gautier
Aix En Provence,  FR 13290
Correspondent Contact Shalyna Bansropun
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/22/2022
Decision Date 10/28/2022
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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