Data / Medical devices / United States / Optovue, Inc.
Optovue, Inc.: FDA-registered device maker in San Jose, CA, United States, 14 510(k) clearances
Optovue, Inc. is registered with the FDA (registration 3005950902) in San Jose, CA, United States. It lists 4 device types. The FDA files 14 510(k) clearances under its listings, the newest dated November 9, 2022. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005950902
- Address
- 231 Charcot Avenue, San Jose, CA, United States, 95131
- Owner or operator
- OPTOVUE, INC. (9091799)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- April 29, 2010
- Registered through
- 2026
- Brand names listed
- AngioVue Imaging System, Avanti, CA (Model: CAM), RTVue 100, RTVue Cam, RTVue Model 100 and 200, RTVue XR, RTVue XR OCT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Ophthalmoscope, Ac-Powered | HLI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tomography, Optical Coherence | OBO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Topographer, Corneal, Ac-Powered | MMQ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 9, 2022 | K222166 | SOLIX | OBO | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| June 8, 2018 | K180660 | Avanti | OBO | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| June 9, 2017 | K163475 | iVue | OBO | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| February 11, 2016 | K153080 | RTVue XR OCT Avanti with AngioVue Software | HLI | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| March 19, 2014 | K133892 | IVUE 500 | HLI | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| July 3, 2013 | K130656 | IFUSION | HKI | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| January 18, 2013 | K121739 | IVUE WITH NORMATIVE DATABASE | HLI | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| January 11, 2013 | K122572 | ICAM FUNDUS CAMERA | HKI | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| April 3, 2012 | K120238 | RTVUE XR OCT | HLI | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| September 8, 2011 | K111505 | RTVUE CAM WITH CORNEAL POWER UPGRADE | OBO | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| September 15, 2010 | K101505 | RTVUE MODEL RTVUE 100 | HLI | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| June 17, 2010 | K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | HLI | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| April 22, 2010 | K091404 | IVUE, MODEL 100 | OBO | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
| September 28, 2007 | K071250 | CA, MODEL: CAM | OBO | Substantially Equivalent | Optovue, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 27, 2017 | 77776 | Class II | Terminated | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | accessdata.fda.gov |
| March 16, 2016 | 73612 | Class II | Terminated | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for | 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. | accessdata.fda.gov |
| May 14, 2013 | 65191 | Class III | Terminated | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. | 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. | accessdata.fda.gov |
| September 7, 2012 | 63211 | Class II | Terminated | Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; | 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. | accessdata.fda.gov |
| February 21, 2012 | 61373 | Not yet classified | Terminated | RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software) | A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version. | accessdata.fda.gov |
| July 20, 2010 | 56759 | Not yet classified | Terminated | Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled opthalmic imaging system. Device scans the patient's eye using low | Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient. | accessdata.fda.gov |
| January 8, 2010 | 54191 | Not yet classified | Terminated | Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA The RTVue is an optical coherence tomography system i | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Ophthalmoscope, Ac-Powered
- All makers of Topographer, Corneal, Ac-Powered
- All makers of Tomography, Optical Coherence
- All makers of Camera, Ophthalmic, Ac-Powered
Updated November 9, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.