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 Mar 3, 2017 as substantially equivalent to K161509 (Topcon Corporation, 2016) after a 44-day review. Its family tree reaches back 8 generations to 2002. 5 later devices descend from it.
- Decided
- Mar 3, 2017
- Review
- 44 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K012727 (2002). 22 ancestors in all, the oldest K946058 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 7 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 6 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 5 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 4 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 3 generations backK091404 Ivue, Model 100Optovue, Inc. · 2010 · Recalled
- 2 generations backK121739 Ivue with Normative DatabaseOptovue, Inc. · 2013 · Recalled
- 1 generation backK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- This deviceK170164 3D OCT-1 MaestroTopcon Corporation · 2017
- Descendant · cites it directly · 3 of its ownK231222 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023
- Descendant · 2 generations on · 2 of its ownK233561 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation · 2024
- Descendant · 3 generations on · 1 of its ownK241081 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6…Topcon Corporation · 2024
- Descendant · 4 generations on · 0 of its ownK253893 Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026
- Descendant · cites it directly · 0 of its ownK173119 DRI OCT TritonTopcon Corporation · 2018
Most influential descendants
Showing 5 of 5 · See all- K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023 · cites it directly3descendants
- K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation · 2024 · 2 generations on2descendants
- K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation · 2024 · 3 generations on1descendant
- K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026 · 4 generations on0descendants
- K173119DRI OCT TritonTopcon Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −7 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −6 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −5 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −4 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −3 | K091404 | Ivue, Model 100 | Optovue, Inc. | 2010 | 2 |
| −2 | K121739 | Ivue with Normative Database | Optovue, Inc. | 2013 | 3 |
| −1 | K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016 | — |
| 0 (this device) | K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017 | — |
| +1 | K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023 | — |
| +2 | K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | 2024 | — |
| +3 | K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6… | Topcon Corporation | 2024 | — |
| +4 | K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | 2026 | — |
| +1 | K173119 | DRI OCT Triton | Topcon Corporation | 2018 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K161509 | 3D OCT-1 MaestroSummary page 4…Classification Name: 21 C.F.R. § 886.1570, Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI Predicate Device: Topcon Corporation’s 3D OCT-1 Maestro (K161509) Device Description The 3D OCT-1 Maestro with new line CCD is a non-contact, high-resolution, tomographic and bio- microscopic i… | 2016 |
What descends from it? (5)
2 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 15 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K231222 (Topcon Corporation, 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K161509.
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 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 fayer, 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 macufa 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 heaith 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/K170164 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170164: 3D OCT-1 Maestro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170164
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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