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Supersonic Imagine

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories1
Latest Approval2024-09-20
TypeNumberDevice NameCodeDate
510(k) K242223 SuperSonic HepaVu IYN 2024-09-20 View
510(k) K222191 Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 IYN 2022-10-28 View
510(k) K203645 Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 IYN 2021-06-29 View
510(k) K202455 Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems IYN 2020-12-29 View
510(k) K191007 Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems IYN 2019-10-25 View
510(k) K180572 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 IYN 2018-05-29 View
510(k) K173021 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems IYN 2018-01-09 View
510(k) K171105 AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems IYN 2017-07-11 View
510(k) K161999 Aixplorer IYN 2016-11-16 View
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