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 its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Ophthalmic Imaging Systems with 5 510(k) clearances. The most recent is a 510(k) clearance dated May 18, 2011: OIS SYMPHONY IMAGE MANAGMENT SYSTEM.
| May 18, 2011 | OIS SYMPHONY IMAGE MANAGMENT SYSTEMK110006 · NFJ | 510(k) clearances |
| Nov 17, 2009 | OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCANK092374 · HKI | 510(k) clearances |
| Oct 23, 1998 | WINSTATION RETINAL IMAGERK982689 · HKI | 510(k) clearances |
| Nov 27, 1991 | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEMK913929 · HKI | 510(k) clearances |
| Oct 9, 1991 | GLAUCOMA-SCOPEK913118 · HLI | 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
