System, Image Management, Ophthalmic

FDA product code NFJ · 48 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.2050
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 2002-11-19 – 2026-07-17

NFJ 2026-07-17

ZEISS CLINIC 360

Applicant Carl Zeiss Meditec, AG

K number K260694

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NFJ 2026-06-04

Harmony Referral System with Harmony OCT Viewer (Octave)

Applicant Topcon Healthcare Solutions EMEA Oy

K number K253893

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NFJ 2024-08-22

iCare ALTIUS CW

Applicant Centervue S.P.A.

K number K234076

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NFJ 2024-03-01

IMAGEnet6 Ophthalmic Data System

Applicant Topcon Corporation

K number K232828

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NFJ 2023-12-21

CALLISTO eye

Applicant Carl Zeiss Meditec, AG

K number K232944

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NFJ 2023-11-20

Harmony

Applicant Topcon Healthcare Solutions

K number K232555

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NFJ 2023-08-28

CALLISTO eye

Applicant Carl Zeiss Meditec, AG

K number K231676

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NFJ 2023-07-31

Altris IMS

Applicant Altris, Inc.

K number K232088

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NFJ 2022-10-31

Excelsior

Applicant Merit Cro, Inc.

K number K220929

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NFJ 2022-08-15

FORUM

Applicant Carl Zeiss Meditec, AG

K number K213527

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NFJ 2022-04-28

RetinAI Discovery

Applicant Retinai Medical AG

K number K211715

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NFJ 2021-09-13

Harmony Referral System

Applicant Topcon Healthcare Solutions EMEA Oy

K number K210396

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NFJ 2021-06-15

CellChek 20 rc

Applicant Konan Medical, Inc.

K number K203244

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NFJ 2020-12-24

Image Quality Analyzer (IQA)

Applicant Visionquest Biomedical, Inc.

K number K200422

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NFJ 2020-09-25

ImageSPECTRUM

Applicant Canon, Inc.

K number K201273

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NFJ 2020-08-03

Glaucoma Module

Applicant Topcon Healthcare Solutions, Inc.

K number K200954

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NFJ 2020-03-16

CONTINUUM PACS

Applicant Integrated Ophthalmic Systems, Inc.

K number K200385

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NFJ 2020-03-03

OVision Imaging System

Applicant Ophthalmic Labs, Inc.

K number K200275

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NFJ 2019-07-18

Huvitz Imaging System

Applicant Huvitz Co., Ltd.

K number K191615

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NFJ 2019-02-12

KOWA VK-2s

Applicant Kowa Co. Ltd. Chofu

K number K190056

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NFJ 2018-11-02

Afina

Applicant Neurovision Imaging, LLC

K number K181501

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NFJ 2018-10-24

Retina Workplace

Applicant Carl Zeiss Meditec, Inc.

K number K182318

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NFJ 2018-09-28

Harmony

Applicant Topcon Medical Systems, Inc.

K number K182376

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NFJ 2018-07-19

Image Filing Software NAVIS-EX

Applicant Nidek Co., Ltd.

K number K181345

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NFJ 2018-07-16

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

Applicant Welch Allyn, Inc.

K number K181016

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NFJ 2018-06-27

CALLISTO eye

Applicant Carl Zeiss Meditec, AG

K number K180858

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NFJ 2018-02-23

Ophthalmic Software Platform RX

Applicant Canon Inc. -Medical Equipment Group

K number K173689

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NFJ 2017-11-01

IMAGEnet 6 Ophthalmic Data System

Applicant Topcon Corporation

K number K171370

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NFJ 2017-06-21

Retina Workplace

Applicant Carl Zeiss Meditec, AG

K number K170638

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NFJ 2017-05-02

AXIS Image Management System

Applicant Sonomed, Inc.

K number K171098

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NFJ 2017-04-06

Huvitz Imaging System

Applicant Huvitz Co., Ltd.

K number K161829

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NFJ 2017-02-08

OptosAdvance 4.0 Software

Applicant Optos Plc.

K number K162039

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NFJ 2013-10-17

IMAGENET 5 PC SOFTWARE SYSTEM

Applicant Topcon Medical Systems, Inc.

K number K132438

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NFJ 2013-10-09

SYNERGY ODM

Applicant Topcon Medical Systems, Inc.

K number K132667

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NFJ 2013-07-23

FORUM GLAUCOMA WORKPLACE

Applicant Carl Zeiss Meditec, AG

K number K130648

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NFJ 2013-04-02

EXCELSIOR

Applicant Eyekor, LLC

K number K130453

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NFJ 2013-03-05

CALLISTO EYE

Applicant Carl Zeiss Meditec, AG

K number K123464

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NFJ 2012-11-02

FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH

Applicant Carl Zeiss Meditec, AG

K number K122938

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NFJ 2012-05-25

OPTOS ADVANCE

Applicant Optos Plc.

K number K113696

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NFJ 2011-07-14

CARA

Applicant Diagnos, Inc.

K number K110869

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NFJ 2011-05-18

OIS SYMPHONY IMAGE MANAGMENT SYSTEM

Applicant Ophthalmic Imaging Systems

K number K110006

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NFJ 2009-12-02

SYNERGY

Applicant Topcon Medical Systems, Inc.

K number K093313

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NFJ 2009-05-06

MATCHEDFLICKER

Applicant Eyeic Corporation

K number K090266

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NFJ 2009-03-25

FORUM

Applicant Carl Zeiss Meditec, Inc.

K number K090439

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NFJ 2009-01-22

IMAGE STORAGE SYSTEM, MODEL KSS-400

Applicant Konan Medical, Inc.

K number K081797

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NFJ 2008-09-30

IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR

Applicant Topcon Corp.

K number K082364

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NFJ 2007-08-31

IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP

Applicant Digital Healthcare, Ltd.

K number K071299

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NFJ 2002-11-19

NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)

Applicant Nidek, Inc.

K number K013694

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