Optovue Inc.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 16
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0009-2018 | Class II | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolutio | July 27, 2017 |
| Z-0008-2018 | Class II | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) i | July 27, 2017 |
| Z-0010-2018 | Class II | iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. I | July 27, 2017 |
| Z-1498-2016 | Class II | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2 | March 16, 2016 |
| Z-1441-2013 | Class III | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in viv | May 14, 2013 |
| Z-0024-2013 | Class II | Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K0914 | September 7, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K222166 | SOLIX | November 9, 2022 |
| K180660 | Avanti | June 8, 2018 |
| K163475 | iVue | June 9, 2017 |
| K153080 | RTVue XR OCT Avanti with AngioVue Software | February 11, 2016 |
| K133892 | IVUE 500 | March 19, 2014 |
| K130656 | IFUSION | July 3, 2013 |
| K121739 | IVUE WITH NORMATIVE DATABASE | January 18, 2013 |
| K122572 | ICAM FUNDUS CAMERA | January 11, 2013 |
| K120238 | RTVUE XR OCT | April 3, 2012 |
| K111505 | RTVUE CAM WITH CORNEAL POWER UPGRADE | September 8, 2011 |
| K103266 | ISTAND | June 3, 2011 |
| K101505 | RTVUE MODEL RTVUE 100 | September 15, 2010 |
| K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | June 17, 2010 |
| K091404 | IVUE, MODEL 100 | April 22, 2010 |
| K071250 | CA, MODEL: CAM | September 28, 2007 |
| K062552 | RTVUE | October 6, 2006 |