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 Healthcare Solutions EMEA Oy and Carl Zeiss Meditec, Inc..
53
Total
53
Cleared
124d
Avg days
2002
Since
53 devices
Cleared
Jul 16, 2018
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
Welch Allyn, Inc.
Ophthalmic
90d
Cleared
Jun 27, 2018
CALLISTO eye
Carl Zeiss Meditec, AG
Ophthalmic
86d
Cleared
Feb 23, 2018
Ophthalmic Software Platform RX
Canon Inc. -Medical Equipment Group
Ophthalmic
84d
Cleared
Jun 21, 2017
Retina Workplace
Carl Zeiss Meditec, AG
Ophthalmic
111d
Cleared
May 21, 2015
Retina Workplace
Carl Zeiss Meditec, AG
Ophthalmic
87d
Cleared
Oct 03, 2014
FORUM GLAUCOMA WORKPLACE
Carl Zeiss Meditec, AG
Ophthalmic
137d
Cleared
Jul 23, 2013
FORUM GLAUCOMA WORKPLACE
Carl Zeiss Meditec, AG
Ophthalmic
134d
Cleared
Mar 05, 2013
CALLISTO EYE
Carl Zeiss Meditec, AG
Ophthalmic
116d
Cleared
Nov 02, 2012
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
Carl Zeiss Meditec, AG
Ophthalmic
39d
Cleared
Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
Nidek, Inc.
Ophthalmic
377d