OIS SYMPHONY IMAGE MANAGMENT SYSTEM— 510(k) K110006
Substantially EquivalentOphthalmic Imaging Systems
FDA 510(k) clearance K110006 for OIS SYMPHONY IMAGE MANAGMENT SYSTEM, Substantially Equivalent on 2011-05-18. Applicant: Ophthalmic Imaging Systems. Device class: 2.
Clearance details
- Applicant
- Ophthalmic Imaging Systems
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
Recent devices under product code NFJ
view allMore clearances from Ophthalmic Imaging Systems
view allRecalls naming K110006
K-number listed on FDA's recall record- Z-2754-2017 — 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 Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
- Z-1681-2017 — Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
- Z-1828-2017 — Merge Eye Station and Merge Eye Care PACS.
- Z-1246-2017 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110006.
Data sourced from openFDA. This site is unofficial and independent of the FDA.