Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in AustraliaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list ImpediMed with 17 510(k) clearances, 4 AI-enabled devices and 1 device recall. The most recent is a 510(k) clearance dated Aug 17, 2026: MySOZO Software version 6.1.0.1 (SW version 6.1.0.1).
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 |
|---|---|---|
| Aug 17, 2026 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)K260224 · DSB | 510(k) clearances |
| Jan 28, 2026 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)K253224 · OBH | 510(k) clearances |
| Oct 17, 2023 | SOZO ProK232089 · DSB | 510(k) clearances |
| Aug 17, 2023 | SOZO Bilateral Arm L-Dex SoftwareClass II · Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema | Device recalls |
| May 4, 2023 | SOZO ProK230530 · OBH | 510(k) clearances |
| May 4, 2023 | SOZO ProK230531 · QJB | 510(k) clearances |
| Apr 19, 2021 | SOZOK203473 · DSB | 510(k) clearances |
| Oct 2, 2020 | SOZO Body Fluid AnalyzerK193410 · DSB | 510(k) clearances |
| Nov 25, 2019 | SOZOK190529 · QJB | 510(k) clearances |
| Nov 25, 2019 | SOZOK190529 · Cardiovascular | AI-enabled devices |
| Apr 16, 2018 | SOZOK180126 · Cardiovascular | AI-enabled devices |
| Dec 22, 2017 | SOZOK172507 · Cardiovascular | AI-enabled devices |
| Aug 11, 2017 | SOZOK172122 · Cardiovascular | 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
