Ophthalmic Imaging Systems: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ophthalmic Imaging Systems” (first 1991, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | 3 | 3 |
| HLI | Ophthalmoscope, Ac-Powered | 1 | 1 |
| NFJ | System, Image Management, Ophthalmic | 1 | 1 |
Review panels
- Ophthalmic (5)
Most recent Ophthalmic Imaging Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110006 | OIS SYMPHONY IMAGE MANAGMENT SYSTEM | NFJ | 2011-05-18 | 135 |
| K092374 | OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN | HKI | 2009-11-17 | 104 |
| K982689 | WINSTATION RETINAL IMAGER | HKI | 1998-10-23 | 81 |
| K913929 | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM | HKI | 1991-11-27 | 85 |
| K913118 | GLAUCOMA-SCOPE | HLI | 1991-10-09 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Ophthalmic Imaging Systems.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ophthalmic Technologies, Inc. (9 510(k)s)
- Ophthalmic Consultants, Inc. (2 510(k)s)
- Ophthalmic Labs, Inc. (1 510(k)s)
- Ophthalmic Resources, Inc. (1 510(k)s)
- Ophthalmic Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ophthalmic Imaging Systems?
FDA lists 5 510(k) clearances under the applicant name “Ophthalmic Imaging Systems” (first 1991, latest 2011), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ophthalmic Imaging Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ophthalmic Imaging Systems is 86 days.
Which FDA product codes appear under Ophthalmic Imaging Systems?
The most frequent FDA product codes under this applicant name are HKI (Camera, Ophthalmic, Ac-Powered, 3); HLI (Ophthalmoscope, Ac-Powered, 1); NFJ (System, Image Management, Ophthalmic, 1).
Next steps
- See all 5 Ophthalmic Imaging Systems clearances with predicates and recalls
- Run predicate analysis for product code HKI, Ophthalmic Imaging Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.