Optovue, Inc.
Medical device manufacturer in Fremont, CA.
16510(k) clearances
0PMA approvals
9recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K222166 | SolixOBO · Traditional | 11/09/2022SE |
| K180660 | AvantiOBO · Traditional | 06/08/2018SE |
| K163475 | iVueOBO · Traditional | 06/09/2017SE |
| K153080 | RTVue XR OCT Avanti with AngioVue SoftwareHLI · Traditional | 02/11/2016SE |
| K133892 | Ivue 500HLI · Traditional | 03/19/2014SE |
| K130656 | IfusionHKI · Special | 07/03/2013SE |
| K121739 | Ivue with Normative DatabaseHLI · Traditional | 01/18/2013SE |
| K122572 | Icam Fundus CameraHKI · Traditional | 01/11/2013SE |
| K120238 | Rtvue XR OctHLI · Special | 04/03/2012SE |
| K111505 | Rtvue Cam with Corneal Power UpgradeOBO · Traditional | 09/08/2011SE |
| K103266 | IstandHLI · Traditional | 06/03/2011SE |
| K101505 | Rtvue Model Rtvue 100HLI · Traditional | 09/15/2010SE |
| K100861 | R T Vue with Software 5.0 Model: R I Vue 100HLI · Special | 06/17/2010SE |
| K091404 | Ivue, Model 100OBO · Traditional | 04/22/2010SE |
| K071250 | Ca, Model: CamOBO · Traditional | 09/28/2007SE |
| K062552 | RtvueOBO · Traditional | 10/06/2006SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0010-2018 Class II | iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging…FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | 07/27/2017Terminated |
| Z-0009-2018 Class II | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high…FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | 07/27/2017Terminated |
| Z-0008-2018 Class II | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue…FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | 07/27/2017Terminated |
| Z-1498-2016 Class II | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA…A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may… | 03/16/2016Terminated |
| Z-1441-2013 Class III | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended…Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version… | 05/14/2013Terminated |
| Z-0024-2013 Class II | Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue…Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina"… | 09/07/2012Terminated |
| Z-1340-2012 | 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… | 02/21/2012Terminated |
| Z-1004-2011 | Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging…Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient. | 07/20/2010Terminated |
| Z-1131-2010 | Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions…Marketed without proper 510(k)-- No 510(k) clearance for Optovue RTVue Model-RT100 with Software Versions… | 01/08/2010Terminated |