System, Image Management, Ophthalmic
Regulation 892.2050
2510(k)s in 12 months (53 all time)
0recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in NFJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Carl Zeiss Meditec, AG | 13 | 1 |
| Topcon Medical Systems, Inc. | 5 | 3 |
| Merge Healthcare, Inc. | 0 | 4 |
| Topcon Corp. | 3 | 0 |
| Bausch & Lomb Inc | 0 | 2 |
| Diagnos, Inc. | 1 | 1 |
| Haag-Streit AG | 1 | 1 |
| Huvitz Co., Ltd. | 2 | 0 |
| Konan Medical, Inc. | 2 | 0 |
| Nidek Co., Ltd. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2025 | MedicalCommunications GmbH Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220).
Device Type: Software (Medical Image Management, Picture Archiving and Communication System) Open, Classified |
NFJ | K200132 |
| Nov 12, 2024 | Topcon Medical Systems, Inc. The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and
management of digital images, patient data, diagnostic data and clinical information Open, Classified |
NFJ | K232828 |
| Jan 11, 2022 | Diagnos Inc CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 Terminated |
NFJ | K110869 |
| Dec 18, 2020 | Topcon Medical Systems, Inc. Harmony Referral System (aka Harmony RS)/ Medical Device
Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms a Terminated |
NFJ | None listed |
| Nov 3, 2020 | Kowa Optimed Inc Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s Terminated |
NFJ | K190056 |
| Apr 12, 2019 | Topcon Medical Systems, Inc. IMAGEnet 6 v1.53-
IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clini Terminated |
NFJ | K171370 |
| Jul 10, 2017 | Merge Healthcare, Inc. Merge Eye Care PACS Viewer 5.2
Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data.
Merge Eye Ca Terminated |
NFJ | K110006 |
| Mar 13, 2017 | Merge Healthcare, Inc. Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU). Terminated |
NFJ | K110006 K913929 |
| Jan 5, 2017 | Haag-Streit USA Inc EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). Terminated |
NFJ | K142423 |
| Apr 4, 2016 | Merge Healthcare, Inc. Merge Eye Station and Merge Eye Care PACS. Terminated |
NFJ | K110006 K913929 |
| Mar 28, 2016 | Merge Healthcare, Inc. Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI. Terminated |
NFJ | K110006 K913929 |
| Feb 4, 2015 | Carl Zeiss Meditec AG FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format).
Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1)
000000-2 Terminated |
NFJ | K122938 |
| May 26, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Vision Enhancement System. Terminated |
NFJ | K063331 |
| May 26, 2010 | Bausch & Lomb Inc Bausch & Lomb Millennium Microsurgical System. Terminated |
NFJ | K961310 |
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