510(k) · Cleared
ClearedOptical Coherence Tomography 3D Oct-2000
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 Sep 2, 2009 as substantially equivalent to K072971 (Topcon Medical Systems, Inc., 2009) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 2007. 14 later devices descend from it.
- Decided
- Sep 2, 2009
- Review
- 21 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K063388 (2007). 3 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK063388 Topcon 3D Oct-1000 Optical Coherence Tomography SystemTopcon Corp. · 2007
- 1 generation backK072971 Topcon 3D Oct-1000 Optical Coherence Tomography System for…Topcon Medical Systems, Inc. · 2009
- This deviceK092470 Optical Coherence Tomography 3D Oct-2000Topcon Corp. · 2009
- Descendant · cites it directly · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · 2 generations on · 5 of its ownK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
- Descendant · 2 generations on · 3 of its ownK150467 Retina WorkplaceCarl Zeiss Meditec, AG · 2015
- Descendant · 2 generations on · 3 of its ownK133217 Cirrus PhotoCarl Zeiss Meditec, AG · 2014
- Descendant · 3 generations on · 2 of its ownK180858 CALLISTO eyeCarl Zeiss Meditec, AG · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · cites it directly13descendants
- K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014 · 2 generations on5descendants
- K150467Retina WorkplaceCarl Zeiss Meditec, AG · 2015 · 2 generations on3descendants
- K133217Cirrus PhotoCarl Zeiss Meditec, AG · 2014 · 2 generations on3descendants
- K180858CALLISTO eyeCarl Zeiss Meditec, AG · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K092470 | Optical Coherence Tomography 3D Oct-2000 | Topcon Corp. | 2009 | — |
| +1 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +2 | K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec, AG | 2014 | — |
| +2 | K150467 | Retina Workplace | Carl Zeiss Meditec, AG | 2015 | — |
| +2 | K133217 | Cirrus Photo | Carl Zeiss Meditec, AG | 2014 | — |
| +3 | K180858 | CALLISTO eye | Carl Zeiss Meditec, AG | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K063888 | 3D OCT-1000 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K072971 | Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal…Summary page 2…egally Marketed Predicate Device The 3D OCT-2000 is substantially equivalent to the 3D OCT-1000 (K06388), 3D OCT-1000 for Measurement of Retinal Thickness (K072971) and 3D OCT- I000 MARK II (K083316). All of those predicate devices are marketed by TOPCON CORPORATION and FDA Produc… | 2009 |
| * | K083316 | 3D Oct-1000 Mark II Optical Coherence Tomography SystemSummary page 2…he 3D OCT-2000 is substantially equivalent to the 3D OCT-1000 (K06388), 3D OCT-1000 for Measurement of Retinal Thickness (K072971) and 3D OCT- I000 MARK II (K083316). All of those predicate devices are marketed by TOPCON CORPORATION and FDA Product Code is OBO. General Description… | 2009 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112184 | Cirrus Photo | 2012 | 13 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112184 (Carl Zeiss Meditec, Inc., 2012) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K072971.
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 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 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 measurement of posterior ocular structures including retina, retinal nerve fiber layer, macula, and optic disk. 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/K092470 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092470: Optical Coherence Tomography 3D Oct-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092470
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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