Supersonic Imagine is one of 174 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
Supersonic Imagine - FDA 510(k) Cleared Devices
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
Supersonic Imagine has 16 FDA 510(k) cleared radiology devices. Based in Aix-En-Provence Cedex, FR.
Latest FDA clearance: Sep 2024. Active since 2009.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Supersonic Imagine
16 devices
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
Aixplorer
Radiology
119d
Cleared
Nov 20, 2014
AIXPLORER
Radiology
111d
Cleared
Sep 24, 2013
AIXPLORER
Radiology
71d
Cleared
Sep 24, 2013
AIXPLORER
Radiology
64d