IVUE, MODEL 100
FDA 510(k) clearance K091404 · decided 2010-04-22
Clearance details
- K-number
- K091404
- Device name
- IVUE, MODEL 100
- Applicant
- Optovue, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-12
- Decision date
- 2010-04-22
- Days to decision
- 345 days
- Clearance type
- Traditional
- Product code
- OBO
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue Sys recall (Z-0024-2013) | Optovue Inc. | 2012-10-09 |
| Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging sy recall (Z-1004-2011) | Optovue Inc. | 2011-02-01 |