510(k) · Cleared
Cleared3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Corporation · OBO Tomography, Optical Coherence
Cleared on Apr 10, 2024 as substantially equivalent to K231222 (Topcon Corporation, 2023) after a 156-day review. Its family tree reaches back 10 generations to 2002. 2 later devices descend from it.
- Decided
- Apr 10, 2024
- Review
- 156 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K012727 (2002). 24 ancestors in all, the oldest K946058 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 6 generations between
- 3 generations backK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- 2 generations backK170164 3D OCT-1 MaestroTopcon Corporation · 2017
- 1 generation backK231222 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023
- This deviceK233561 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation · 2024
- Descendant · cites it directly · 1 of its ownK241081 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6…Topcon Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK253893 Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026
Show all 10 generations
- Root · 10 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 9 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 8 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 7 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 6 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 5 generations backK091404 Ivue, Model 100Optovue, Inc. · 2010 · Recalled
- 4 generations backK121739 Ivue with Normative DatabaseOptovue, Inc. · 2013 · Recalled
- 3 generations backK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- 2 generations backK170164 3D OCT-1 MaestroTopcon Corporation · 2017
- 1 generation backK231222 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023
- This deviceK233561 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −9 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −8 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −7 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −6 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −5 | K091404 | Ivue, Model 100 | Optovue, Inc. | 2010 | 2 |
| −4 | K121739 | Ivue with Normative Database | Optovue, Inc. | 2013 | 3 |
| −3 | K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016 | — |
| −2 | K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017 | — |
| −1 | K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023 | — |
| 0 (this device) | K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | 2024 | — |
| +1 | K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6… | Topcon Corporation | 2024 | — |
| +2 | K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Summary page 4…ompany Topcon Corporation Device 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) 510(k) No. K231222 Topcon Corporation Page 1 of 9 Brief Device Description 3D O… | 2023 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data… | 2024 | 1 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K241081 (Topcon Corporation, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions. The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross…
Read the full statement (164 words)
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)is indicated for use as a diagnostic 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/K233561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233561: 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233561
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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