# K110006: Ois Symphony Image Managment System

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Imaging Systems
- Decided: May 18, 2011 after 135 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K896095 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090439: FORUM, Carl Zeiss Meditec, Inc. (2009) Summary page 2.
- K013694: Nidek Advanced Vision Information System (Navis), Nidek, Inc. (2002) Summary page 2.
- K093313: Synergy, Topcon Medical Systems, Inc. (2009) Summary page 2.

## Recalls of this device
- Jun 13, 2017 · Class II · Z-2754-2017: When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an i
- Apr 4, 2016 · Class II · Z-1681-2017: The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
- Apr 4, 2016 · Class II · Z-1828-2017: During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.
- Mar 28, 2016 · Class II · Z-1246-2017: Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)

## Indications for use
OIS Symphony is a comprehensive software platform for the import, integration and review of patient data and clinical information in an eye care environment. OIS Symphony allows for the collection, management, enhancement and review of the patient demographics, image data, diagnostic data and clinical reports from a variety of medical devices through either a direct connection with the instruments or through computerized networks.

Source page: https://510kreport.com/device/K110006
Methodology: https://510kreport.com/methodology