Product Code: NFJ FDA class 2 21 CFR 892.2050

System, Image Management, Ophthalmic

Radiology

The System, Image Management, Ophthalmic (product code NFJ) is a radiology/ophthalmic device system used to manage, organize, archive, and retrieve ophthalmic diagnostic images within a clinical or hospital environment. It is classified as an FDA Class 2 device within the Radiology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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FEI Numbers

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Unique Applicants

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Basic Information

Product Code: NFJ
Device Class: FDA class 2
Regulation Number: 892.2050
Medical Specialty: Radiology
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 52 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253893	Harmony Referral System with Harmony OCT Viewer (Octave)	Jun 04, 2026	Substantially Equivalent	Topcon Healthcare Solutions EMEA Oy
K234076	iCare ALTIUS CW	Aug 22, 2024	Substantially Equivalent	Centervue S.P.A.
K232828	IMAGEnet6 Ophthalmic Data System	Mar 01, 2024	Substantially Equivalent	Topcon Corporation
K232944	CALLISTO eye	Dec 21, 2023	Substantially Equivalent	Carl Zeiss Meditec, AG
K232555	Harmony	Nov 20, 2023	Substantially Equivalent	Topcon Healthcare Solutions
K231676	CALLISTO eye	Aug 28, 2023	Substantially Equivalent	Carl Zeiss Meditec, AG
K232088	Altris IMS	Jul 31, 2023	Substantially Equivalent	Altris, Inc.
K220929	Excelsior	Oct 31, 2022	Substantially Equivalent	Merit Cro, Inc.
K213527	FORUM	Aug 15, 2022	Substantially Equivalent	Carl Zeiss Meditec, AG
K211715	RetinAI Discovery	Apr 28, 2022	Substantially Equivalent	Retinai Medical AG
K210396	Harmony Referral System	Sep 13, 2021	Substantially Equivalent	Topcon Healthcare Solutions EMEA Oy
K203244	CellChek 20 rc	Jun 15, 2021	Substantially Equivalent	Konan Medical, Inc.
K200422	Image Quality Analyzer (IQA)	Dec 24, 2020	Substantially Equivalent	Visionquest Biomedical, Inc.
K201273	ImageSPECTRUM	Sep 25, 2020	Substantially Equivalent	Canon, Inc.
K200954	Glaucoma Module	Aug 03, 2020	Substantially Equivalent	Topcon Healthcare Solutions, Inc.
K200385	CONTINUUM PACS	Mar 16, 2020	Substantially Equivalent	Integrated Ophthalmic Systems, Inc.
K200275	OVision Imaging System	Mar 03, 2020	Substantially Equivalent	Ophthalmic Labs, Inc.
K191615	Huvitz Imaging System	Jul 18, 2019	Substantially Equivalent	Huvitz Co., Ltd.
K190056	KOWA VK-2s	Feb 12, 2019	Substantially Equivalent	Kowa Co. Ltd. Chofu
K181501	Afina	Nov 02, 2018	Substantially Equivalent	Neurovision Imaging, LLC
K182318	Retina Workplace	Oct 24, 2018	Substantially Equivalent	Carl Zeiss Meditec, Inc.
K182376	Harmony	Sep 28, 2018	Substantially Equivalent	Topcon Medical Systems, Inc.
K181345	Image Filing Software NAVIS-EX	Jul 19, 2018	Substantially Equivalent	Nidek Co., Ltd.
K181016	Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System	Jul 16, 2018	Substantially Equivalent	Welch Allyn, Inc.
K180858	CALLISTO eye	Jun 27, 2018	Substantially Equivalent	Carl Zeiss Meditec, AG
K173689	Ophthalmic Software Platform RX	Feb 23, 2018	Substantially Equivalent	Canon Inc. -Medical Equipment Group
K171370	IMAGEnet 6 Ophthalmic Data System	Nov 01, 2017	Substantially Equivalent	Topcon Corporation
K170638	Retina Workplace	Jun 21, 2017	Substantially Equivalent	Carl Zeiss Meditec, AG
K171098	AXIS Image Management System	May 02, 2017	Substantially Equivalent	Sonomed, Inc.
K161829	Huvitz Imaging System	Apr 06, 2017	Substantially Equivalent	Huvitz Co., Ltd.
K162039	OptosAdvance 4.0 Software	Feb 08, 2017	Substantially Equivalent	Optos Plc.
K151952	Synergy ODM	Oct 01, 2015	Substantially Equivalent	Topcon Medical Systems, Inc.
K150467	Retina Workplace	May 21, 2015	Substantially Equivalent	Carl Zeiss Meditec, AG
K141922	IRIS INTELLIGENT RETINAL IMAGING SYSTEM	Feb 27, 2015	Substantially Equivalent	Intelligent Retinal Imaging Systems, LLC
K141297	FORUM GLAUCOMA WORKPLACE	Oct 03, 2014	Substantially Equivalent	Carl Zeiss Meditec, AG
K142423	EyeSuite Imaging	Sep 10, 2014	Substantially Equivalent	Haag-Streit AG
K132438	IMAGENET 5 PC SOFTWARE SYSTEM	Oct 17, 2013	Substantially Equivalent	Topcon Medical Systems, Inc.
K132667	SYNERGY ODM	Oct 09, 2013	Substantially Equivalent	Topcon Medical Systems, Inc.
K130648	FORUM GLAUCOMA WORKPLACE	Jul 23, 2013	Substantially Equivalent	Carl Zeiss Meditec, AG
K130453	EXCELSIOR	Apr 02, 2013	Substantially Equivalent	Eyekor, LLC
K123464	CALLISTO EYE	Mar 05, 2013	Substantially Equivalent	Carl Zeiss Meditec, AG
K122938	FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH	Nov 02, 2012	Substantially Equivalent	Carl Zeiss Meditec, AG
K113696	OPTOS ADVANCE	May 25, 2012	Substantially Equivalent	Optos Plc.
K110869	CARA	Jul 14, 2011	Substantially Equivalent	Diagnos, Inc.
K110006	OIS SYMPHONY IMAGE MANAGMENT SYSTEM	May 18, 2011	Substantially Equivalent	Ophthalmic Imaging Systems
K093313	SYNERGY	Dec 02, 2009	Substantially Equivalent	Topcon Medical Systems, Inc.
K090266	MATCHEDFLICKER	May 06, 2009	Substantially Equivalent	Eyeic Corporation
K090439	FORUM	Mar 25, 2009	Substantially Equivalent	Carl Zeiss Meditec, Inc.
K081797	IMAGE STORAGE SYSTEM, MODEL KSS-400	Jan 22, 2009	Substantially Equivalent	Konan Medical, Inc.
K082364	IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR	Sep 30, 2008	Substantially Equivalent	Topcon Corp.
K071299	IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP	Aug 31, 2007	Substantially Equivalent	Digital Healthcare, Ltd.
K013694	NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)	Nov 19, 2002	Substantially Equivalent	Nidek, Inc.