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, Topcon Corporation and Centervue S.P.A..
FDA 510(k) Cleared System, Image Management, Ophthalmic Devices (Product Code NFJ)
About Product Code NFJ - Regulatory Context
510(k) Submission Activity
51 total 510(k) submissions under product code NFJ since 2002, with 51 receiving FDA clearance (average review time: 123 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 7 in the prior period.
FDA Review Time
Recent submissions under NFJ have taken an average of 245 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.
NFJ devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →