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 13, 2026, FDA's public records list Echosens with 11 510(k) clearances. The most recent is a 510(k) clearance dated Mar 2, 2023: FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630).
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.
| Date | Record | Source |
|---|---|---|
| Mar 2, 2023 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)K223902 · IYO | 510(k) clearances |
| Jul 30, 2021 | FibroScan 230K212035 · IYO | 510(k) clearances |
| Mar 25, 2021 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)K203273 · IYO | 510(k) clearances |
| Jul 16, 2020 | FibroScan® 630K200655 · IYO | 510(k) clearances |
| Jul 9, 2018 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)K181547 · IYO | 510(k) clearances |
| Nov 14, 2017 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)K173034 · IYO | 510(k) clearances |
| Sep 13, 2017 | FibroScan 430 Mini+K172142 · IYO | 510(k) clearances |
| Mar 18, 2016 | FibroScan 530 CompactK160524 · IYO | 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
