Ois Symphony Image Managment System

510(k) K110006

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK110006	Date18 May 2011Cleared	StatusActive

4 recalls · FDA

- Terminated Z-2754-2017 FDA Class II initiated 13 Jun 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 image, ECP may then read that image as OS when it is, in fact, OD.
- Terminated Z-1681-2017 FDA Class II initiated 4 Apr 2016
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
- Terminated Z-1828-2017 FDA Class II initiated 4 Apr 2016
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.
- Terminated Z-1246-2017 FDA Class II initiated 28 Mar 2016
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)

1 jurisdiction

United States — FDA 510(k) Active

510(k)