510(k) · Cleared
Cleared3D OCT-1 Maestro
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 Jul 28, 2016 as substantially equivalent to K121739 (Optovue, Inc., 2013) and 1 other predicate after a 57-day review. Its family tree reaches back 7 generations to 2002. 8 later devices descend from it.
- Decided
- Jul 28, 2016
- Review
- 57 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K012727 (2002). 21 ancestors in all, the oldest K946058 (1995). 8 later devices descend from it, 3 citing it directly.
- 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 deviceK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- Descendant · cites it directly · 5 of its ownK170164 3D OCT-1 MaestroTopcon Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK231222 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023
- Descendant · cites it directly · 3 of its ownK171370 IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK233561 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation · 2024
- Descendant · 2 generations on · 2 of its ownK232828 IMAGEnet6 Ophthalmic Data SystemTopcon Corporation · 2024 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K1701643D OCT-1 MaestroTopcon Corporation · 2017 · cites it directly5descendants
- K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023 · 2 generations on3descendants
- K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · cites it directly3descendants
- K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation · 2024 · 3 generations on2descendants
- K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation · 2024 · 2 generations on2descendants
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) | K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016 | — |
| +1 | K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017 | — |
| +2 | K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023 | — |
| +1 | K171370 | IMAGEnet 6 Ophthalmic Data System | Topcon Corporation | 2017 | 1 |
| +3 | K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | 2024 | — |
| +2 | K232828 | IMAGEnet6 Ophthalmic Data System | Topcon Corporation | 2024 | 1 |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K121739 | Ivue with Normative DatabaseSummary page 4…I, 21 C.F.R. § 886.1570 Product Code(s): OBO, HKI Predicate Device(s): Primary Predicate: Optovue’s iVue with Normative Database (K121739) Secondary Predicate: Topcon’s TRC-NW300 Non-Mydriatic Retinal Camera (K123460) \\DC - 026811/000013 - 858867… | 2013 |
| * | K123460 | TRC-NW300 Non-Mydriatic Retinal CameraSummary page 4…rimary Predicate: Optovue’s iVue with Normative Database (K121739) Secondary Predicate: Topcon’s TRC-NW300 Non-Mydriatic Retinal Camera (K123460) \\DC - 026811/000013 - 8588672 v1 Indications for Use: The Topcon 3D OCT-1 Maestro is a non-contact, high r… | 2013 |
| † | K092470 | Optical Coherence Tomography 3D Oct-2000 | 2009 |
What descends from it? (8)
3 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)
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 14 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K170164 (Topcon Corporation, 2017) has gone furthest, with 5 descendants of its own.
- 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. 2016, 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 OCT-1 Maestro is a non-contact, 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 3D OCT-1 Maestro is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures…
Read the full statement (151 words)
The Topcon 3D OCT-1 Maestro is a non-contact, 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 3D OCT-1 Maestro 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 3D OCT-1 Maestro 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/K161509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161509: 3D OCT-1 Maestro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161509
Report an extraction error
Are you the manufacturer?
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