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 Optovue with 16 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Nov 9, 2022: SOLIX.
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 |
|---|---|---|
| Nov 9, 2022 | SOLIXK222166 · OBO | 510(k) clearances |
| Jun 8, 2018 | AvantiK180660 · OBO | 510(k) clearances |
| Jun 9, 2017 | iVueK163475 · OBO | 510(k) clearances |
| Feb 11, 2016 | RTVue XR OCT Avanti with AngioVue SoftwareK153080 · HLI | 510(k) clearances |
| Mar 19, 2014 | IVUE 500K133892 · HLI | 510(k) clearances |
| Jul 3, 2013 | IFUSIONK130656 · HKI | 510(k) clearances |
| Jan 18, 2013 | IVUE WITH NORMATIVE DATABASEK121739 · HLI | 510(k) clearances |
| Jan 11, 2013 | ICAM FUNDUS CAMERAK122572 · HKI | 510(k) clearances |
| Sep 7, 2012 | Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped withClass II · Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provid | Device recalls |
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
