OIS SYMPHONY IMAGE MANAGMENT SYSTEM
FDA 510(k) clearance K110006 · decided 2011-05-18
Clearance details
- K-number
- K110006
- Device name
- OIS SYMPHONY IMAGE MANAGMENT SYSTEM
- Applicant
- Ophthalmic Imaging Systems
- Decision
- Substantially Equivalent
- Date received
- 2011-01-03
- Decision date
- 2011-05-18
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- NFJ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
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|---|---|---|
| Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, recall (Z-2754-2017) | Merge Healthcare, Inc. | 2017-07-10 |
| Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Ey recall (Z-1681-2017) | Merge Healthcare, Inc. | 2017-03-13 |