Medical Device Manufacturer · FR , Aix-En-Provence Cedex

Supersonic Imagine - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2009

Recent clearances: SuperSonic HepaVu, Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40, Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40

16
Total
16
Cleared
0
Denied

FDA 510(k) Regulatory Record - Supersonic Imagine Radiology ✕

16 devices
1-16 of 16
Cleared Sep 20, 2024
SuperSonic HepaVu
K242223 · IYN
Radiology · 53d
Cleared Oct 28, 2022
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20,...
K222191 · IYN
Radiology · 98d
Cleared Jun 29, 2021
Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20,...
K203645 · IYN
Radiology · 197d
Cleared Dec 29, 2020
Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 &...
K202455 · IYN
Radiology · 124d
Cleared Oct 25, 2019
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
K191007 · IYN
Radiology · 192d
Cleared May 29, 2018
AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer...
K180572 · IYN
Radiology · 85d
Cleared Jan 09, 2018
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
K173021 · IYN
Radiology · 103d
Cleared Jul 11, 2017
AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
K171105 · IYN
Radiology · 89d
Cleared Nov 16, 2016
Aixplorer
K161999 · IYN
Radiology · 119d
Cleared Nov 20, 2014
AIXPLORER
K142100 · IYN
Radiology · 111d
Cleared Sep 24, 2013
AIXPLORER
K132171 · IYN
Radiology · 71d
Cleared Sep 24, 2013
AIXPLORER
K132274 · IYN
Radiology · 64d
Cleared Aug 28, 2012
AIXPLORER
K112255 · IYN
Radiology · 389d
Cleared Aug 24, 2012
AIXPLORER
K121329 · IYN
Radiology · 114d
Cleared Oct 13, 2010
AIXPLORER
K102041 · ITX
Radiology · 86d
Cleared Aug 12, 2009
AIXPLORER ULTRASOUND SYSTEM
K091970 · IYN
Radiology · 42d
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