Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40

System, Imaging, Pulsed Doppler, Ultrasonic

SuperSonic Imagine

The following data is part of a premarket notification filed by Supersonic Imagine with the FDA for Aixplorer Mach30 / Supersonic Mach30, Aixplorer Mach20 / Supersonic , Mach20, Supersonic Mach40.

Pre-market Notification Details

Device IDK222191
510k NumberK222191
Device Name:Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SuperSonic Imagine Zac De L`enfant 135 Rue Emilien Gautier Aix En Provence,  FR 13290
ContactShalyna Bansropun
CorrespondentShalyna Bansropun
SuperSonic Imagine Zac De L`enfant 135 Rue Emilien Gautier Aix En Provence,  FR 13290
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-22
Decision Date2022-10-28

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