Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ophthalmic Imaging Systems — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
135 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110006 | OIS SYMPHONY IMAGE MANAGMENT SYSTEM | Ophthalmic Imaging Systems | 2011-05-18 | 135 | 2 |
| K092374 | OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESC | Ophthalmic Imaging Systems | 2009-11-17 | 104 | 0 |
| K982689 | WINSTATION RETINAL IMAGER | Ophthalmic Imaging Systems | 1998-10-23 | 81 | 1 |
| K913929 | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM | Ophthalmic Imaging Systems | 1991-11-27 | 85 | 1 |
| K913118 | GLAUCOMA-SCOPE | Ophthalmic Imaging Systems | 1991-10-09 | 86 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda