NFJ · Class II · 21 CFR 892.2050

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
25–48 of 53
Cleared Jul 16, 2018
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
K181016
Welch Allyn, Inc.
Ophthalmic · 90d
Cleared Jun 27, 2018
CALLISTO eye
K180858
Carl Zeiss Meditec, AG
Ophthalmic · 86d
Cleared Feb 23, 2018
Ophthalmic Software Platform RX
K173689
Canon Inc. -Medical Equipment Group
Ophthalmic · 84d
Cleared Nov 01, 2017
IMAGEnet 6 Ophthalmic Data System
K171370
Topcon Corporation
Ophthalmic · 175d
Cleared Jun 21, 2017
Retina Workplace
K170638
Carl Zeiss Meditec, AG
Ophthalmic · 111d
Cleared May 02, 2017
AXIS Image Management System
K171098
Sonomed, Inc.
Ophthalmic · 19d
Cleared Apr 06, 2017
Huvitz Imaging System
K161829
Huvitz Co., Ltd.
Ophthalmic · 275d
Cleared Feb 08, 2017
OptosAdvance 4.0 Software
K162039
Optos Plc.
Ophthalmic · 201d
Cleared Oct 01, 2015
Synergy ODM
K151952
Topcon Medical Systems, Inc.
Ophthalmic · 78d
Cleared May 21, 2015
Retina Workplace
K150467
Carl Zeiss Meditec, AG
Ophthalmic · 87d
Cleared Feb 27, 2015
IRIS INTELLIGENT RETINAL IMAGING SYSTEM
K141922
Intelligent Retinal Imaging Systems, LLC
Ophthalmic · 226d
Cleared Oct 03, 2014
FORUM GLAUCOMA WORKPLACE
K141297
Carl Zeiss Meditec, AG
Ophthalmic · 137d
Cleared Sep 10, 2014
EyeSuite Imaging
K142423
Haag-Streit AG
Ophthalmic · 13d
Cleared Oct 17, 2013
IMAGENET 5 PC SOFTWARE SYSTEM
K132438
Topcon Medical Systems, Inc.
Ophthalmic · 73d
Cleared Oct 09, 2013
SYNERGY ODM
K132667
Topcon Medical Systems, Inc.
Ophthalmic · 43d
Cleared Jul 23, 2013
FORUM GLAUCOMA WORKPLACE
K130648
Carl Zeiss Meditec, AG
Ophthalmic · 134d
Cleared Apr 02, 2013
EXCELSIOR
K130453
Eyekor, LLC
Ophthalmic · 39d
Cleared Mar 05, 2013
CALLISTO EYE
K123464
Carl Zeiss Meditec, AG
Ophthalmic · 116d
Cleared Nov 02, 2012
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
K122938
Carl Zeiss Meditec, AG
Ophthalmic · 39d
Cleared May 25, 2012
OPTOS ADVANCE
K113696
Optos Plc.
Ophthalmic · 161d
Cleared Jul 14, 2011
CARA
K110869
Diagnos, Inc.
Ophthalmic · 107d
Cleared May 18, 2011
OIS SYMPHONY IMAGE MANAGMENT SYSTEM
K110006
Ophthalmic Imaging Systems
Ophthalmic · 135d
Cleared Mar 25, 2009
FORUM
K090439
Carl Zeiss Meditec, Inc.
Ophthalmic · 33d
Cleared Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K013694
Nidek, Inc.
Ophthalmic · 377d