Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Supersonic Imagine

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K242223 SuperSonic HepaVuIYN2024-09-20 View
510(k) K222191 Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40IYN2022-10-28 View
510(k) K203645 Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40IYN2021-06-29 View
510(k) K202455 Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic SystemsIYN2020-12-29 View
510(k) K191007 Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsIYN2019-10-25 View
510(k) K180572 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10IYN2018-05-29 View
510(k) K173021 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsIYN2018-01-09 View
510(k) K171105 AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsIYN2017-07-11 View
510(k) K161999 AixplorerIYN2016-11-16 View
510(k) K132171 AIXPLORERIYN2013-09-24 View
510(k) K132274 AIXPLORERIYN2013-09-24 View
510(k) K112255 AIXPLORERIYN2012-08-28 View
510(k) K121329 AIXPLORERIYN2012-08-24 View
510(k) K102041 AIXPLORERITX2010-10-13 View
510(k) K091970 AIXPLORER ULTRASOUND SYSTEMIYN2009-08-12 View
↑