510(k) · Cleared
Recalled · Class II · 2012Ivue, Model 100
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 Apr 22, 2010 as substantially equivalent to K062552 (Optovue, Inc., 2006) and 1 other predicate after a 345-day review. Its family tree reaches back 5 generations to 2002. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 22, 2010
- Review
- 345 days
- Class
- Class II
- Product code
- OBO
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K012727 (2002). 7 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 4 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 3 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 2 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 1 generation backK071250 CA, Model: CamOptovue, Inc. · 2007
- This deviceK091404 Ivue, Model 100Optovue, Inc. · 2010
- Descendant · cites it directly · 14 of its ownK121739 Ivue with Normative DatabaseOptovue, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 8 of its ownK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- Descendant · 3 generations on · 5 of its ownK170164 3D OCT-1 MaestroTopcon Corporation · 2017
- Descendant · 4 generations on · 3 of its ownK231222 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023
- Descendant · 3 generations on · 3 of its ownK171370 IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K121739Ivue with Normative DatabaseOptovue, Inc. · 2013 · cites it directly14descendants
- K1615093D OCT-1 MaestroTopcon Corporation · 2016 · 2 generations on8descendants
- K1701643D OCT-1 MaestroTopcon Corporation · 2017 · 3 generations on5descendants
- K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023 · 4 generations on3descendants
- K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −4 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −3 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −2 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −1 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| 0 (this device) | K091404 | Ivue, Model 100 | Optovue, Inc. | 2010 | — |
| +1 | K121739 | Ivue with Normative Database | Optovue, Inc. | 2013 | 3 |
| +2 | K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016 | — |
| +3 | K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017 | — |
| +4 | K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023 | — |
| +3 | K171370 | IMAGEnet 6 Ophthalmic Data System | Topcon Corporation | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K062552 | RTVUESummary page 1…Optical Coherence Tomography (OCT) Classification Name: Ophthalmoscope, a-c powered (21 CFR§ 886.1570) Predicate Devices (1) RTVue (K062552) (2) CA (K071250) Intended Use The iVue is an optical coherence tomography system indicated for the in vivo imaging and mea… | 2006 |
| * | K071250 | CA, Model: CamSummary page 1…rence Tomography (OCT) Classification Name: Ophthalmoscope, a-c powered (21 CFR§ 886.1570) Predicate Devices (1) RTVue (K062552) (2) CA (K071250) Intended Use The iVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retin… | 2007 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2012 | Class II | Z-0024-2013 | No Marketing Application | Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli… |
| Jul 20, 2010 | Not classified | Z-1004-2011 | Software design (manufacturing process) | Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K121739 (Optovue, Inc., 2013) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K062552.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, cornea, and anterior chamber of the eye as an aid in the diagnosis and management of ocular diseases
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091404 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091404: Ivue, Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091404
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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