Company ยท US
Optovue, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2022. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 2022 | K222166 | SOLIX Optovue, Inc. | OBO |
| Jun 8, 2018 | K180660 | Avanti Optovue, Inc. | OBO |
| Jun 9, 2017 | K163475 | iVue Optovue, Inc. | OBO |
| Feb 11, 2016 | K153080 | RTVue XR OCT Avanti with AngioVue Software Optovue, Inc. | HLI |
| Mar 19, 2014 | K133892 | IVUE 500 Optovue, Inc. | HLI |
| Jul 3, 2013 | K130656 | IFUSION Optovue, Inc. | HKI |
| Jan 18, 2013 | K121739 | IVUE WITH NORMATIVE DATABASE Optovue, Inc. | HLI |
| Jan 11, 2013 | K122572 | ICAM FUNDUS CAMERA Optovue, Inc. | HKI |
| Apr 3, 2012 | K120238 | RTVUE XR OCT Optovue, Inc. | HLI |
| Sep 8, 2011 | K111505 | RTVUE CAM WITH CORNEAL POWER UPGRADE Optovue, Inc. | OBO |
| Jun 3, 2011 | K103266 | ISTAND Optovue, Inc. | HLI |
| Sep 15, 2010 | K101505 | RTVUE MODEL RTVUE 100 Optovue, Inc. | HLI |
| Jun 17, 2010 | K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 Optovue, Inc. | HLI |
| Apr 22, 2010 | K091404 | IVUE, MODEL 100 Optovue, Inc. | OBO |
| Sep 28, 2007 | K071250 | CA, MODEL: CAM Optovue, Inc. | OBO |
| Oct 6, 2006 | K062552 | RTVUE Optovue, Inc. | OBO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2017 | Optovue, Inc. iVue 500 with iScan, D216606.
Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measureme Terminated |
HLI | K133892 |
| Jul 27, 2017 | Optovue, Inc. iFusion, Device Listing Number D203271.
Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the r Terminated |
HKI | K130656 |
| Jul 27, 2017 | Optovue, Inc. 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, axi Terminated |
HLI | K121739 |
| Mar 16, 2016 | Optovue, Inc. 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 dev Terminated |
HLI | K121739 K133892 |
| May 31, 2013 | Optovue, Inc. Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.
Intended for in vivo imaging. Terminated |
HLI | K121739 |
| Oct 9, 2012 | Optovue Inc. 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: Terminated |
OBO | K091404 K101505 |
| Mar 30, 2012 | Optovue Inc. RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software) Terminated |
OBO | K111505 |
| Feb 1, 2011 | Optovue Inc. Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA
Computer controlled opthalmic imaging system. Device scans the pat Terminated |
NQQ | K091404 |
| Mar 15, 2010 | Optovue Inc. 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 coherenc Terminated |
OBO | None listed |