510(k) · Cleared
ClearedTopcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal Thickness
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Medical Systems, Inc. · OBO Tomography, Optical Coherence
Cleared on Jan 13, 2009 as substantially equivalent to K063388 (Topcon Corp., 2007) after a 449-day review. Its family tree reaches back 1 generation to 2007. 39 later devices descend from it.
- Decided
- Jan 13, 2009
- Review
- 449 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063388 (2007). 39 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK063388 Topcon 3D Oct-1000 Optical Coherence Tomography SystemTopcon Corp. · 2007
- This deviceK072971 Topcon 3D Oct-1000 Optical Coherence Tomography System for…Topcon Medical Systems, Inc. · 2009
- Descendant · cites it directly · 29 of its ownK093313 SynergyTopcon Medical Systems, Inc. · 2009
- Descendant · 2 generations on · 25 of its ownK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
- Descendant · cites it directly · 14 of its ownK092470 Optical Coherence Tomography 3D Oct-2000Topcon Corp. · 2009
- Descendant · 2 generations on · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK132667 Synergy OdmTopcon Medical Systems, Inc. · 2013
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K093313SynergyTopcon Medical Systems, Inc. · 2009 · cites it directly29descendants
- K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · 2 generations on25descendants
- K092470Optical Coherence Tomography 3D Oct-2000Topcon Corp. · 2009 · cites it directly14descendants
- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · 2 generations on13descendants
- K132667Synergy OdmTopcon Medical Systems, Inc. · 2013 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063388 | Topcon 3D Oct-1000 Optical Coherence Tomography System | Topcon Corp. | 2007 | — |
| 0 (this device) | K072971 | Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of… | Topcon Medical Systems, Inc. | 2009 | — |
| +1 | K093313 | Synergy | Topcon Medical Systems, Inc. | 2009 | — |
| +2 | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist Match | Carl Zeiss Meditec, AG | 2012 | 1 |
| +1 | K092470 | Optical Coherence Tomography 3D Oct-2000 | Topcon Corp. | 2009 | — |
| +2 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +2 | K132667 | Synergy Odm | Topcon Medical Systems, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K063388 | Topcon 3D Oct-1000 Optical Coherence Tomography SystemSummary page 2…f the eye to obtain cross-sectional images of the retina. The Topcon 3D OCT-1000 for Measurement of Retinal Thickness is identical to the FDA-cleared Topcon 3D OCT-1000 (K063388), with the exception of the addition of a new software module allowing for the measurement of retinal thickness.… | 2007 |
| * | — | STRATUSOCT with Retinal Nerve Fiber Layer and Macula Normative Database Named without a submission number | |
| * | — | RTA 5 & RTA Model E Retinal Thickness Analyzer Named without a submission number | |
| * | — | RTA Retinal Thickness Analyzer Named without a submission number |
What descends from it? (39)
See all 392 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?
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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-1000 is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial, cross-sectional and three-dimensional imaging and measurements of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072971: Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal Thickness.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072971
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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