510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Supersonic Imagine

Aix-En-Provence Cedex, FR

Supersonic Imagine appears in FDA device records in Aix-En-Provence Cedex, FR. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 16 510(k) clearances for Supersonic Imagine between 2009 and 2024. The busiest year on record is 2012, with 2. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Supersonic Imagine, by decision year
YearClearances
20091
20101
20122
20132
20141
20161
20171
20182
20191
20201
20211
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242223SuperSonic HepaVuIYNSubstantially Equivalent
K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40IYNSubstantially Equivalent
K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40IYNSubstantially Equivalent
K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic SystemsIYNSubstantially Equivalent
K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsIYNSubstantially Equivalent
K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10IYNSubstantially Equivalent
K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsIYNSubstantially Equivalent
K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsIYNSubstantially Equivalent
K161999AixplorerIYNSubstantially Equivalent
K142100AIXPLORERIYNSubstantially Equivalent
K132274AIXPLORERIYNSubstantially Equivalent
K132171AIXPLORERIYNSubstantially Equivalent
K112255AIXPLORERIYNSubstantially Equivalent
K121329AIXPLORERIYNSubstantially Equivalent
K102041AIXPLORERITXSubstantially Equivalent
K091970AIXPLORER ULTRASOUND SYSTEMIYNSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain