Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list EchoNous with 5 510(k) clearances, 4 AI-enabled devices and 1 device recall. The most recent is a 510(k) clearance dated Apr 25, 2025: Kosmos.
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 |
|---|---|---|
| Apr 25, 2025 | KosmosK242321 · IYN | 510(k) clearances |
| Aug 29, 2024 | KosmosK233826 · IYN | 510(k) clearances |
| Aug 29, 2024 | KosmosK233826 · Radiology | AI-enabled devices |
| May 9, 2024 | Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.Class II · Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed me | Device recalls |
| Aug 6, 2021 | KosmosK212100 · IYN | 510(k) clearances |
| Aug 6, 2021 | KosmosK212100 · Radiology | AI-enabled devices |
| Mar 26, 2020 | KOSMOSK193518 · IYN | 510(k) clearances |
| Mar 26, 2020 | KOSMOSK193518 · Radiology | AI-enabled devices |
| Jul 10, 2018 | UscanK181574 · IYO | 510(k) clearances |
| Jul 10, 2018 | UscanK181574 · Radiology | AI-enabled devices |
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
