FDA 510(k) Applications Submitted by Optovue, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100861 |
03/26/2010 |
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 |
OPTOVUE, INC. |
| K091404 |
05/12/2009 |
IVUE, MODEL 100 |
OPTOVUE, INC. |
| K121739 |
06/13/2012 |
IVUE WITH NORMATIVE DATABASE |
OPTOVUE, INC. |
| K122572 |
08/23/2012 |
ICAM FUNDUS CAMERA |
OPTOVUE, INC. |
| K153080 |
10/23/2015 |
RTVue XR OCT Avanti with AngioVue Software |
OPTOVUE, INC. |
| K163475 |
12/12/2016 |
iVue |
Optovue, Inc. |
| K180660 |
03/14/2018 |
Avanti |
Optovue, Inc. |
| K071250 |
05/04/2007 |
CA, MODEL: CAM |
OPTOVUE, INC. |
| K062552 |
08/30/2006 |
RTVUE |
OPTOVUE, INC. |
| K111505 |
05/31/2011 |
RTVUE CAM WITH CORNEAL POWER UPGRADE |
OPTOVUE, INC. |
| K101505 |
06/01/2010 |
RTVUE MODEL RTVUE 100 |
OPTOVUE, INC. |
| K120238 |
01/26/2012 |
RTVUE XR OCT |
OPTOVUE, INC. |
| K103266 |
11/04/2010 |
ISTAND |
OPTOVUE, INC. |
| K133892 |
12/20/2013 |
IVUE 500 |
OPTOVUE, INC. |
| K222166 |
07/21/2022 |
SOLIX |
Optovue, Inc. |
| K130656 |
03/12/2013 |
IFUSION |
OPTOVUE, INC. |
|
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