510(k) Report

FDA applicant

Supersonic Imagine

Aix-En-Provence Cedex, FR16 decisions2009–20240 recalls

FDA records 16 decisions for Supersonic Imagine (Aix-En-Provence Cedex, FR) from 2009 to 2024: 16 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 85 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 20 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Supersonic Imagine’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 12010: 12012: 22013: 22014: 12016: 12017: 12018: 22019: 12020: 12021: 12022: 12024: 1
2009high 2 (2012) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Supersonic Imagine by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Supersonic Imagine’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic15decisions
  • ITXTransducer, Ultrasonic, Diagnostic1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 103 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 85 days; 2 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 39 predicates; 20 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 20 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K112255AixplorerSupersonic Imagine · 20129cite it
  • K132274AixplorerSupersonic Imagine · 20136cite it
  • K121329AixplorerSupersonic Imagine · 20125cite it
  • K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine · 20193cite it
  • K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 20182cite it
  • K091970Aixplorer Ultrasound SystemSupersonic Imagine · 20092cite it

What has FDA decided for it lately?

  • K242223SuperSonic HepaVuSupersonic Imagine · 2024
  • K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40Supersonic Imagine · 2022
  • K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40Supersonic Imagine · 2021
  • K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic…Supersonic Imagine · 2020
  • K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine · 2019
  • K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10Supersonic Imagine · 2018
  • K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018
  • K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine · 2017

All 16 as Supersonic Imagine →