Data / Medical devices / System, Image Management, Ophthalmic / United States
FDA-registered makers of System, Image Management, Ophthalmic in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make System, Image Management, Ophthalmic (product code NFJ). 10 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- System, Image Management, Ophthalmic
- Product code
- NFJ
- Country
- United States
Makers of System, Image Management, Ophthalmic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Topcon Healthcare, Inc. | Oakland, NJ, United States | Manufacturer | 4 | November 20, 2023 | 0 | 3 | 0 | api.fda.gov |
| Integrated Ophthalmic Systems, Inc. | Woburn, MA, United States | Manufacturer | 1 | March 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Intelligent Retinal Imaging Systems, Inc. | Pensacola, FL, United States | Manufacturer | 1 | February 27, 2015 | 0 | 0 | 0 | api.fda.gov |
| MERIT CRO, Inc. | Madison, WI, United States | Manufacturer | 1 | April 2, 2013 | 0 | 0 | 0 | api.fda.gov |
| Merge Healthcare Incorporated | Hartland, WI, United States | Manufacturer | 1 | May 18, 2011 | 0 | 4 | 0 | api.fda.gov |
| Neurovision Imaging, Inc. | Sacramento, CA, United States | Specification developer | 1 | November 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 1 | July 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Ophthalmic Labs, Inc. | Milton, MA, United States | Manufacturer | 1 | March 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Sonomed, Inc. | Westbury, NY, United States | Manufacturer | 1 | May 2, 2017 | 0 | 0 | 0 | api.fda.gov |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer | 1 | July 16, 2018 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.