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 Medical Systems, Inc. and Optos Plc..
53
Total
53
Cleared
124d
Avg days
2002
Since
53 devices
Cleared
Mar 25, 2009
FORUM
Carl Zeiss Meditec, Inc.
Ophthalmic
33d
Cleared
Jan 22, 2009
IMAGE STORAGE SYSTEM, MODEL KSS-400
Konan Medical, Inc.
Ophthalmic
211d
Cleared
Sep 30, 2008
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR
Topcon Corp.
Ophthalmic
43d
Cleared
Aug 31, 2007
IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
Digital Healthcare, Ltd.
Ophthalmic
114d
Cleared
Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
Nidek, Inc.
Ophthalmic
377d