510(k) Report

FDA applicant

Optovue, Inc.

Fremont, CA16 decisions2006–20228 recalls

FDA records 16 decisions for Optovue, Inc. (Fremont, CA) from 2006 to 2022: 16 510(k) clearances. Most are in product codes OBO (Tomography, Optical Coherence) and HLI (Ophthalmoscope, Ac-Powered). Its devices cite 26 predicates, 20 of them its own earlier devices. 8 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Optovue, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 12010: 32011: 22012: 12013: 32014: 12016: 12017: 12018: 12022: 1
2007high 3 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2017

2010: 12012: 22013: 12016: 12017: 3
2007high 3 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Optovue, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Optovue, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OBOTomography, Optical Coherence7decisions
  • HLIOphthalmoscope, Ac-Powered7decisions
  • HKICamera, Ophthalmic, Ac-Powered2decisions

Whose devices does it build on?

Its devices cite 26 predicates; 20 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 20 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K121739Ivue with Normative DatabaseOptovue, Inc. · 20136cite it
  • K071250CA, Model: CamOptovue, Inc. · 20075cite it
  • K122572Icam Fundus CameraOptovue, Inc. · 20134cite it
  • K101505Rtvue Model Rtvue 100Optovue, Inc. · 20104cite it
  • K180660AvantiOptovue, Inc. · 20183cite it
  • K062552RTVUEOptovue, Inc. · 20063cite it

What has FDA decided for it lately?

  • K222166SOLIXOptovue, Inc. · 2022
  • K180660AvantiOptovue, Inc. · 2018
  • K163475iVueOptovue, Inc. · 2017
  • K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
  • K133892IVUE 500Optovue, Inc. · 20142 recalls
  • K130656IfusionOptovue, Inc. · 20131 recall
  • K121739Ivue with Normative DatabaseOptovue, Inc. · 20133 recalls
  • K122572Icam Fundus CameraOptovue, Inc. · 2013

All 16 as Optovue, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K121739iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue…Jul 27, 2017Class II
  • K130656iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high…Jul 27, 2017Class II
  • K133892iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging…Jul 27, 2017Class II
  • K121739iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA…Mar 16, 2016Class II
  • K121739Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended…May 14, 2013Class III
  • K091404Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue…Sep 7, 2012Class II