Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Supersonic Imagine — Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

103 daysmedian FDA review time
197 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242223SuperSonic HepaVuSupersonic Imagine2024-09-20530
K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPSupersonic Imagine2022-10-28980
K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSupersonic Imagine2021-06-291970
K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, SuperSupersonic Imagine2020-12-291240
K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SSupersonic Imagine2019-10-251920
K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach Supersonic Imagine2018-05-29850
K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine2018-01-091030
K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine2017-07-11890
K161999AixplorerSupersonic Imagine2016-11-161190
K142100AIXPLORERSupersonic Imagine2014-11-201110
K132171AIXPLORERSupersonic Imagine2013-09-24710
K132274AIXPLORERSupersonic Imagine2013-09-24640
K112255AIXPLORERSupersonic Imagine2012-08-283890
K121329AIXPLORERSupersonic Imagine2012-08-241140
K102041AIXPLORERSupersonic Imagine2010-10-13860
K091970AIXPLORER ULTRASOUND SYSTEMSupersonic Imagine2009-08-12420

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda