510(k) · Cleared
Cleared3D Oct-1000 Mark II Optical Coherence Tomography System
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 Mar 13, 2009 as substantially equivalent to K063388 (Topcon Corp., 2007) after a 123-day review. Its family tree reaches back 1 generation to 2007. 15 later devices descend from it.
- Decided
- Mar 13, 2009
- Review
- 123 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063388 (2007). 15 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK063388 Topcon 3D Oct-1000 Optical Coherence Tomography SystemTopcon Corp. · 2007
- This deviceK083316 3D Oct-1000 Mark II Optical Coherence Tomography SystemTopcon Medical Systems, Inc. · 2009
- 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 · 3 generations on · 5 of its ownK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
- Descendant · 3 generations on · 3 of its ownK150467 Retina WorkplaceCarl Zeiss Meditec, AG · 2015
- Descendant · 3 generations on · 3 of its ownK133217 Cirrus PhotoCarl Zeiss Meditec, AG · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K092470Optical Coherence Tomography 3D Oct-2000Topcon Corp. · 2009 · cites it directly14descendants
- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · 2 generations on13descendants
- K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014 · 3 generations on5descendants
- K150467Retina WorkplaceCarl Zeiss Meditec, AG · 2015 · 3 generations on3descendants
- K133217Cirrus PhotoCarl Zeiss Meditec, AG · 2014 · 3 generations on3descendants
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) | K083316 | 3D Oct-1000 Mark II Optical Coherence Tomography System | Topcon Medical Systems, Inc. | 2009 | — |
| +1 | K092470 | Optical Coherence Tomography 3D Oct-2000 | Topcon Corp. | 2009 | — |
| +2 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +3 | K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec, AG | 2014 | — |
| +3 | K150467 | Retina Workplace | Carl Zeiss Meditec, AG | 2015 | — |
| +3 | K133217 | Cirrus Photo | Carl Zeiss Meditec, AG | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K063388 | Topcon 3D Oct-1000 Optical Coherence Tomography SystemSummary page 1…evice The 3D OCT-1000 MARK Ib is substantially equivalent to the 3D OCT-1000 Optical Coherence Tomography System marketed by Topcon, 510(k) Premarket Notification Number K063388, FDA Product Code OBO. General Description The Topcon 3D OCT-]000 is a non-contact ophthalmic imaging system for… | 2007 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092470 | Optical Coherence Tomography 3D Oct-2000 | 2009 | 14 |
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 MARK II 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/K083316 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083316: 3D Oct-1000 Mark II Optical Coherence Tomography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083316
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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