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Supersonic Imagine

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242223SuperSonic HepaVuSeptember 20, 2024
K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40October 28, 2022
K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40June 29, 2021
K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 UltrasoDecember 29, 2020
K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsOctober 25, 2019
K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10May 29, 2018
K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsJanuary 9, 2018
K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsJuly 11, 2017
K161999AixplorerNovember 16, 2016
K142100AIXPLORERNovember 20, 2014
K132274AIXPLORERSeptember 24, 2013
K132171AIXPLORERSeptember 24, 2013
K112255AIXPLORERAugust 28, 2012
K121329AIXPLORERAugust 24, 2012
K102041AIXPLOREROctober 13, 2010
K091970AIXPLORER ULTRASOUND SYSTEMAugust 12, 2009