FDA 510(k) Applications Submitted by Supersonic Imagine

FDA 510(k) Number Submission Date Device Name Applicant
K132171 07/15/2013 AIXPLORER SUPERSONIC IMAGINE
K142100 08/01/2014 AIXPLORER SUPERSONIC IMAGINE
K132274 07/22/2013 AIXPLORER SUPERSONIC IMAGINE
K191007 04/16/2019 Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems Supersonic Imagine
K121329 05/02/2012 AIXPLORER SUPERSONIC IMAGINE
K091970 07/01/2009 AIXPLORER ULTRASOUND SYSTEM SUPERSONIC IMAGINE
K102041 07/19/2010 AIXPLORER SUPERSONIC IMAGINE
K112255 08/05/2011 AIXPLORER SUPERSONIC IMAGINE
K202455 08/27/2020 Aixplorer«MACH20, Aixplorer«MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems Supersonic Imagine
K203645 12/14/2020 Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 SuperSonic Imagine
K180572 03/05/2018 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 Supersonic Imagine
K171105 04/13/2017 AIXPLORER« & AIXPLORER« Ultimate Ultrasound Systems Supersonic Imagine
K161999 07/20/2016 Aixplorer SUPERSONIC IMAGINE
K173021 09/28/2017 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems Supersonic Imagine
K222191 07/22/2022 Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 SuperSonic Imagine


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