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 Topcon Healthcare Solutions EMEA Oy.
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
Nov 01, 2017
IMAGEnet 6 Ophthalmic Data System
Topcon Corporation
Ophthalmic
175d
Cleared
Jun 21, 2017
Retina Workplace
Carl Zeiss Meditec, AG
Ophthalmic
111d
Cleared
May 02, 2017
AXIS Image Management System
Sonomed, Inc.
Ophthalmic
19d
Cleared
Apr 06, 2017
Huvitz Imaging System
Huvitz Co., Ltd.
Ophthalmic
275d
Cleared
Feb 08, 2017
OptosAdvance 4.0 Software
Optos Plc.
Ophthalmic
201d
Cleared
Oct 01, 2015
Synergy ODM
Topcon Medical Systems, Inc.
Ophthalmic
78d
Cleared
May 21, 2015
Retina Workplace
Carl Zeiss Meditec, AG
Ophthalmic
87d
Cleared
Feb 27, 2015
IRIS INTELLIGENT RETINAL IMAGING SYSTEM
Intelligent Retinal Imaging Systems, LLC
Ophthalmic
226d
Cleared
Oct 03, 2014
FORUM GLAUCOMA WORKPLACE
Carl Zeiss Meditec, AG
Ophthalmic
137d
Cleared
Sep 10, 2014
EyeSuite Imaging
Haag-Streit AG
Ophthalmic
13d
Cleared
Oct 17, 2013
IMAGENET 5 PC SOFTWARE SYSTEM
Topcon Medical Systems, Inc.
Ophthalmic
73d
Cleared
Oct 09, 2013
SYNERGY ODM
Topcon Medical Systems, Inc.
Ophthalmic
43d
Cleared
Jul 23, 2013
FORUM GLAUCOMA WORKPLACE
Carl Zeiss Meditec, AG
Ophthalmic
134d
Cleared
Apr 02, 2013
EXCELSIOR
Eyekor, LLC
Ophthalmic
39d
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
May 25, 2012
OPTOS ADVANCE
Optos Plc.
Ophthalmic
161d
Cleared
Jul 14, 2011
CARA
Diagnos, Inc.
Ophthalmic
107d
Cleared
May 18, 2011
OIS SYMPHONY IMAGE MANAGMENT SYSTEM
Ophthalmic Imaging Systems
Ophthalmic
135d
Cleared
Mar 25, 2009
FORUM
Carl Zeiss Meditec, Inc.
Ophthalmic
33d
Cleared
Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
Nidek, Inc.
Ophthalmic
377d