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

Supersonic Imagine - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2009

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

Radiology · 53d

Cleared Oct 28, 2022

Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20,...

Radiology · 98d

Cleared Jun 29, 2021

Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20,...

Radiology · 197d

Cleared Dec 29, 2020

Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 &...

Radiology · 124d

Cleared Oct 25, 2019

Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems

Radiology · 192d

Cleared May 29, 2018

AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer...

Radiology · 85d

Cleared Jan 09, 2018

Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems

Radiology · 103d

Cleared Jul 11, 2017

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems

Radiology · 89d

Cleared Nov 16, 2016

Radiology · 119d

Cleared Nov 20, 2014

Radiology · 111d

Cleared Sep 24, 2013

Radiology · 71d

Cleared Sep 24, 2013

Radiology · 64d

Cleared Aug 28, 2012

Radiology · 389d

Cleared Aug 24, 2012

Radiology · 114d

Cleared Oct 13, 2010

Radiology · 86d

Cleared Aug 12, 2009

AIXPLORER ULTRASOUND SYSTEM

Radiology · 42d