510(k) · Cleared
ClearedTopcon 3D Oct-1000 Optical Coherence Tomography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Corp. · OBO Tomography, Optical Coherence
Cleared on Jun 22, 2007 after a 226-day review. The FDA summary names its predicate without a number. 41 later devices descend from it.
- Decided
- Jun 22, 2007
- Review
- 226 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 2 citing it directly.
- This deviceK063388 Topcon 3D Oct-1000 Optical Coherence Tomography SystemTopcon Corp. · 2007
- Descendant · cites it directly · 39 of its ownK072971 Topcon 3D Oct-1000 Optical Coherence Tomography System for…Topcon Medical Systems, Inc. · 2009
- Descendant · 2 generations on · 29 of its ownK093313 SynergyTopcon Medical Systems, Inc. · 2009
- Descendant · 3 generations on · 25 of its ownK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
- Descendant · cites it directly · 15 of its ownK083316 3D Oct-1000 Mark II Optical Coherence Tomography SystemTopcon Medical Systems, Inc. · 2009
- Descendant · 2 generations on · 14 of its ownK092470 Optical Coherence Tomography 3D Oct-2000Topcon Corp. · 2009
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K072971Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal…Topcon Medical Systems, Inc. · 2009 · cites it directly39descendants
- K093313SynergyTopcon Medical Systems, Inc. · 2009 · 2 generations on29descendants
- K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · 3 generations on25descendants
- K0833163D Oct-1000 Mark II Optical Coherence Tomography SystemTopcon Medical Systems, Inc. · 2009 · cites it directly15descendants
- K092470Optical Coherence Tomography 3D Oct-2000Topcon Corp. · 2009 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063388 | Topcon 3D Oct-1000 Optical Coherence Tomography System | Topcon Corp. | 2007 | — |
| +1 | K072971 | Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of… | Topcon Medical Systems, Inc. | 2009 | — |
| +2 | K093313 | Synergy | Topcon Medical Systems, Inc. | 2009 | — |
| +3 | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist Match | Carl Zeiss Meditec, AG | 2012 | 1 |
| +1 | K083316 | 3D Oct-1000 Mark II Optical Coherence Tomography System | Topcon Medical Systems, Inc. | 2009 | — |
| +2 | K092470 | Optical Coherence Tomography 3D Oct-2000 | Topcon Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 4 | 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? (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 |
|---|---|---|---|
| * | — | Carl Zeiss, Inc., Humphrey OCT Scanner Named without a submission number | |
| * | — | Carl Zeiss Ophthalmic Systems, Inc.'s, Humphrey OCT 3 Named without a submission number |
What descends from it? (41)
See all 412 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?
- Of its descendants, K072971 (Topcon Medical Systems, Inc., 2009) has gone furthest, with 39 descendants 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. 2007, 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 ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063388 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063388: Topcon 3D Oct-1000 Optical Coherence Tomography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063388
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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