Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Supersonic Imagine with 16 510(k) clearances. The most recent is a 510(k) clearance dated Sep 20, 2024: SuperSonic HepaVu.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 20, 2024 | SuperSonic HepaVuK242223 · IYN | 510(k) clearances |
| Oct 28, 2022 | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40K222191 · IYN | 510(k) clearances |
| Jun 29, 2021 | Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40K203645 · IYN | 510(k) clearances |
| Dec 29, 2020 | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic SystemsK202455 · IYN | 510(k) clearances |
| Oct 25, 2019 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsK191007 · IYN | 510(k) clearances |
| May 29, 2018 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10K180572 · IYN | 510(k) clearances |
| Jan 9, 2018 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsK173021 · IYN | 510(k) clearances |
| Jul 11, 2017 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsK171105 · IYN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
