FDA Product Code NFJ: System, Image Management, Ophthalmic
Efficient image management is essential in high-volume ophthalmic practices. FDA product code NFJ covers ophthalmic image management systems used to store, display, and analyze ocular images.
These systems integrate images from fundus cameras, OCT, visual field analyzers, and other ophthalmic instruments into a unified database, enabling comparison across visits for disease progression monitoring and documentation.
NFJ devices are Class II medical devices, regulated under 21 CFR 892.2050 and reviewed by the FDA Ophthalmic panel.
Leading manufacturers include Carl Zeiss Meditec, AG.
List of System, Image Management, Ophthalmic devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Image Management, Ophthalmic devices (product code NFJ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Ophthalmic FDA review panel. Browse all Ophthalmic devices →