510(k) · Cleared
Recalled · Class II · 2017Ivue with Normative Database
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optovue, Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Jan 18, 2013 as substantially equivalent to K091404 (Optovue, Inc., 2010) and 1 other predicate after a 219-day review. Its family tree reaches back 6 generations to 2002. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 18, 2013
- Review
- 219 days
- Class
- Class II
- Product code
- HLI
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 6 generations to K012727 (2002). 9 ancestors in all. 14 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 5 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 4 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 3 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 2 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 1 generation backK091404 Ivue, Model 100Optovue, Inc. · 2010 · Recalled
- This deviceK121739 Ivue with Normative DatabaseOptovue, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- Descendant · 2 generations on · 5 of its ownK170164 3D OCT-1 MaestroTopcon Corporation · 2017
- Descendant · 3 generations on · 3 of its ownK231222 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023
- Descendant · 2 generations on · 3 of its ownK171370 IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · Recalled
- Descendant · 4 generations on · 2 of its ownK233561 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K1615093D OCT-1 MaestroTopcon Corporation · 2016 · cites it directly8descendants
- K1701643D OCT-1 MaestroTopcon Corporation · 2017 · 2 generations on5descendants
- K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023 · 3 generations on3descendants
- K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · 2 generations on3descendants
- K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −5 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −4 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −3 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −2 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −1 | K091404 | Ivue, Model 100 | Optovue, Inc. | 2010 | 2 |
| 0 (this device) | K121739 | Ivue with Normative Database | Optovue, Inc. | 2013 | — |
| +1 | K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016 | — |
| +2 | K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017 | — |
| +3 | K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023 | — |
| +2 | K171370 | IMAGEnet 6 Ophthalmic Data System | Topcon Corporation | 2017 | 1 |
| +4 | K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 HLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K091404 | Ivue, Model 100Summary page 1…CER§ 886.1570) Classification: Class 11 (ace. 21 CFR 886.1570) Product Code: HLI Predicate Devices. (1) iVue® (K091404) - manufactured by Optovue, Inc. (2) RTVue® with Normative Database (KIO0 1505) - manufactured by Optovue, Inc.… | 2010 |
| * | K101505 | Rtvue Model Rtvue 100Summary page 2…RTVue with NDB. iVue with NDB, based on the same Optical Coherence Tomography (OCT) technology that is used in the predicate device iVue (K09 1404) and RTVue with NDB (K 101505), is a non- invasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RT… | 2010 |
What descends from it? (14)
See all 146 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 |
|---|---|---|---|---|
| Jul 27, 2017 | Class II | Z-0008-2018 | Other | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| Mar 16, 2016 | Class II | Z-1498-2016 | Under Investigation by firm | A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map. |
| May 14, 2013 | Class III | Z-1441-2013 | Software design | Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K161509 (Topcon Corporation, 2016) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K091404.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HLI
112in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HLI
2in 2024
MAUDE reports naming product code HLI, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 36 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 4 | 112 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 2 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
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 (0CC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber…
Read the full statement (110 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 (0CC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database 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 with Normative Database 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121739: Ivue with Normative Database.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121739
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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