510(k) · Cleared
ClearediVue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optovue, Inc. · OBO Tomography, Optical Coherence
Cleared on Jun 9, 2017 as substantially equivalent to K121739 (Optovue, Inc., 2013) after a 179-day review. Its family tree reaches back 7 generations to 2002.
- Decided
- Jun 9, 2017
- Review
- 179 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K012727 (2002). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 6 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 5 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 4 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 3 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 2 generations backK091404 Ivue, Model 100Optovue, Inc. · 2010 · Recalled
- 1 generation backK121739 Ivue with Normative DatabaseOptovue, Inc. · 2013 · Recalled
- This deviceK163475 iVueOptovue, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −6 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −5 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −4 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −3 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −2 | K091404 | Ivue, Model 100 | Optovue, Inc. | 2010 | 2 |
| −1 | K121739 | Ivue with Normative Database | Optovue, Inc. | 2013 | 3 |
| 0 (this device) | K163475 | iVue | Optovue, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OBO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OBO device
- #1 K250868 SPECTRALIS HRA+OCT and variantsscore 16.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121739 | Ivue with Normative DatabaseSummary page 4…1 CFR§ 886.1570 Device Class: II Predicate Device Company: Optovue, Inc. Device: iVue with Normative Database (K121739) Intended Use The iVue is an optical coherence tomography system intended for in vivo imaging, axial cross- sectional, three-d… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 10 ancestors have a recall of any class.
- 5 other devices also cite its predicate K121739.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OBO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBO
125in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBO
4in 2025
MAUDE reports naming product code OBO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 4 | 151 | 0 | 0 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 2 | — | 2 | 0 |
| 2012 | 3 | 269 | 2 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 152 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 4 | 125 | 0 | 1 |
| 2017 | 4 | 118 | 0 | 0 |
| 2018 | 6 | 87 | 1 | 1 |
| 2019 | 5 | 249 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 1 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 7 | 262 | 0 | 3 |
| 2024 | 8 | 157 | 0 | 3 |
| 2025 | 3 | 125 | 0 | 4 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in-vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, corneal epithelia, corneal stroma and anterior chamber of the eye. With the integrated normative database, the iVue is a quantitative tool for…
Read the full statement (112 words)
The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in-vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, corneal epithelia, corneal stroma and anterior chamber of the eye. With the integrated normative database, the iVue is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163475 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163475: iVue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163475
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026