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 Healthcare Solutions EMEA Oy and Canon, Inc..

52
Total
52
Cleared
124d
Avg days
2002
Since
Declining activity - 2 submissions in the last 2 years vs 7 in the prior period
Review times increasing: avg 214d recently vs 121d historically

FDA 510(k) Cleared System, Image Management, Ophthalmic Devices (Product Code NFJ)

52 devices
1–24 of 52
Cleared Jun 04, 2026
Harmony Referral System with Harmony OCT Viewer (Octave)
K253893
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 182d
Cleared Aug 22, 2024
iCare ALTIUS CW
K234076
Centervue S.P.A.
Ophthalmic · 245d
Cleared Mar 01, 2024
IMAGEnet6 Ophthalmic Data System
K232828
Topcon Corporation
Ophthalmic · 170d
Cleared Dec 21, 2023
CALLISTO eye
K232944
Carl Zeiss Meditec, AG
Ophthalmic · 92d
Cleared Nov 20, 2023
Harmony
K232555
Topcon Healthcare Solutions
Ophthalmic · 89d
Cleared Aug 28, 2023
CALLISTO eye
K231676
Carl Zeiss Meditec, AG
Ophthalmic · 80d
Cleared Jul 31, 2023
Altris IMS
K232088
Altris, Inc.
Ophthalmic · 18d
Cleared Oct 31, 2022
Excelsior
K220929
Merit Cro, Inc.
Ophthalmic · 214d
Cleared Aug 15, 2022
FORUM
K213527
Carl Zeiss Meditec, AG
Ophthalmic · 284d
Cleared Apr 28, 2022
RetinAI Discovery
K211715
Retinai Medical AG
Ophthalmic · 329d
Cleared Sep 13, 2021
Harmony Referral System
K210396
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 215d
Cleared Jun 15, 2021
CellChek 20 rc
K203244
Konan Medical, Inc.
Ophthalmic · 224d
Cleared Dec 24, 2020
Image Quality Analyzer (IQA)
K200422
Visionquest Biomedical, Inc.
Ophthalmic · 308d
Cleared Sep 25, 2020
ImageSPECTRUM
K201273
Canon, Inc.
Ophthalmic · 136d
Cleared Aug 03, 2020
Glaucoma Module
K200954
Topcon Healthcare Solutions, Inc.
Ophthalmic · 116d
Cleared Mar 16, 2020
CONTINUUM PACS
K200385
Integrated Ophthalmic Systems, Inc.
Ophthalmic · 27d
Cleared Mar 03, 2020
OVision Imaging System
K200275
Ophthalmic Labs, Inc.
Ophthalmic · 28d
Cleared Jul 18, 2019
Huvitz Imaging System
K191615
Huvitz Co., Ltd.
Ophthalmic · 30d
Cleared Feb 12, 2019
KOWA VK-2s
K190056
Kowa Co. Ltd. Chofu
Ophthalmic · 32d
Cleared Nov 02, 2018
Afina
K181501
Neurovision Imaging, LLC
Ophthalmic · 148d
Cleared Oct 24, 2018
Retina Workplace
K182318
Carl Zeiss Meditec, Inc.
Ophthalmic · 58d
Cleared Sep 28, 2018
Harmony
K182376
Topcon Medical Systems, Inc.
Ophthalmic · 28d
Cleared Jul 19, 2018
Image Filing Software NAVIS-EX
K181345
Nidek Co., Ltd.
Ophthalmic · 59d
Cleared Jul 16, 2018
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
K181016
Welch Allyn, Inc.
Ophthalmic · 90d

About Product Code NFJ - Regulatory Context

510(k) Submission Activity

52 total 510(k) submissions under product code NFJ since 2002, with 52 receiving FDA clearance (average review time: 124 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 7 in the prior period.

FDA 510(k) Review Time - NFJ Product Code

Recent submissions under NFJ have taken an average of 214 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 →