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Sign in to claim this brandOPTOVUE, INC.
United States·US-MF-000018369
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 231, Charcot Avenue, San Jose, United States
- Website
- www.visionix.com
- —
- —
- [email protected]
- Phone
- +1 800 729 1959
- PRRC Contact
- Peter Sparacio
- EUDAMED SRN
- US-MF-000018369
- FDA FEI Number
- 3005950902
- DUNS Number
- 196500461
Catalogue (86)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Solix Essential | Solix Essential | EUDAMED | Class IIa | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| RTVue XR Avanti | 100 | FDA UDI | Class II | Active |
| RTVue XR Avanti | 100-1 | FDA UDI | Class II | Active |
| iVue | iVue 100-1 | FDA UDI | Class II | Active |
| iVue | iVue 100-1 | FDA UDI | Class II | Active |
| iVue | iVue 100-1 | FDA UDI | Class II | Active |
| iCam | iCam100 | FDA UDI | Class II | Active |
| iFusion | iFusion | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| iCam | iCam100 | FDA UDI | Class II | Active |
| iScan | iVue 500 | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| iVue | iVue 100-1 | FDA UDI | Class II | Active |
| iFusion | iFusion | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| Vivicon | Vivicon | FDA UDI | Class II | Active |
| Avanti | RTVue XR Scanner | FDA UDI | Class II | Active |
| iFusion | iFusion | FDA UDI | Class II | Active |
| RTVue XR Avanti | 100 | FDA UDI | Class II | Active |
| iVue | iVue 100-1 | FDA UDI | Class II | Active |
| iFusion | iFusion | FDA UDI | Class II | Active |
| Avanti | RTVue XR100-1 | FDA UDI | Class II | Active |
| Avanti | RTVue XR100-2 | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| iFusion | iFusion | FDA UDI | Class II | Active |
| RTVue XR Avanti | 100 | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| iFusion | iFusion | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| iVue | iVue 100-2 | FDA UDI | Class II | Active |
| RTVue XR Avanti | 100-2 | FDA UDI | Class II | Active |
| iFusion | iFusion | FDA UDI | Class II | Active |
| iFusion | iFusion | FDA UDI | Class II | Active |
| iVue | iVue 100-2 | FDA UDI | Class II | Active |
| iStand | iStand | FDA UDI | Class II | Active |
| iVue | iVue 100 | FDA UDI | Class II | Active |
| iVue | iVue 100-2 | FDA UDI | Class II | Active |
| iFusion | iFusion | FDA UDI | Class II | Active |
| iFusion | iFusion | FDA UDI | Class II | Active |
| iCam | iCam100 | FDA UDI | Class II | Active |
| RTVue XR Avanti Scanner | Avanti Scanner | FDA UDI | Class II | Active |
| iScan | iVue 500 | FDA UDI | Class II | Active |
| RTVue XR Avanti | 100 | FDA UDI | Class II | Active |
| RTVue XR Avanti | 100 | FDA UDI | Class II | Active |
| iVue | iVue 100-2 | FDA UDI | Class II | Active |
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FDA Recalls (9)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 27, 2017 | Z-0008-2018 | — | terminated | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| Jul 27, 2017 | Z-0009-2018 | — | terminated | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| Jul 27, 2017 | Z-0010-2018 | — | terminated | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| Mar 16, 2016 | Z-1498-2016 | — | terminated | A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map. |
| May 14, 2013 | Z-1441-2013 | — | terminated | Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports. |
| Sep 7, 2012 | Z-0024-2013 | — | terminated | Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description. |
| Feb 21, 2012 | Z-1340-2012 | — | terminated | A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version. |
| Jul 20, 2010 | Z-1004-2011 | — | terminated | Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient. |
| Jan 8, 2010 | Z-1131-2010 | — | terminated | Marketed without proper 510(k)-- No 510(k) clearance for Optovue RTVue Model-RT100 with Software Versions 3.0.x.x and higher which includes the Normative Database. |