510(k) · Cleared
ClearedTomophase Octis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomophase Corporation · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Dec 1, 2010 as substantially equivalent to K033783 (Imalux Coporation, 2004) after an 82-day review. Its family tree reaches back 2 generations to 1994. 10 later devices descend from it.
- Decided
- Dec 1, 2010
- Review
- 82 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944523 (1994). 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK944523 Humphrey Oct (Optical Coherence Tomography) ScannerHumphrey, Inc. · 1994
- 1 generation backK033783 Imalux Oct Imaging SystemImalux Coporation · 2004
- This deviceK102599 Tomophase OctisTomophase Corporation · 2010
- Descendant · cites it directly · 9 of its ownK112770 Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK120800 Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013
- Descendant · 3 generations on · 5 of its ownK143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 2 of its ownK153479 NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon…Ninepoint Medical, Inc. · 2016
- Descendant · 5 generations on · 1 of its ownK182616 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011 · cites it directly9descendants
- K120800Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013 · 2 generations on6descendants
- K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc. · 2015 · 3 generations on5descendants
- K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc. · 2016 · 4 generations on2descendants
- K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc. · 2018 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944523 | Humphrey Oct (Optical Coherence Tomography) Scanner | Humphrey, Inc. | 1994 | — |
| −1 | K033783 | Imalux Oct Imaging System | Imalux Coporation | 2004 | — |
| 0 (this device) | K102599 | Tomophase Octis | Tomophase Corporation | 2010 | — |
| +1 | K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | Ninepoint Medical, Inc. | 2011 | — |
| +2 | K120800 | Nvision Vle Imaging System | Ninepoint Medical, Inc. | 2013 | — |
| +3 | K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation… | Ninepoint Medical, Inc. | 2015 | 1 |
| +4 | K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE… | Ninepoint Medical, Inc. | 2016 | — |
| +5 | K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | Ninepoint Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 NQQ? 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 NQQ device
- #1 K251730 LIA Console (542-7)score 16.2 · 20 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 |
|---|---|---|---|
| * | K033783 | Imalux Oct Imaging SystemSummary page 1…lence is being claimed with the Imalux OCT Imaging following legally marketed predicate device: System Predicate device 510(k) number: K033783 D. Description of the device [21 CFR 807.92(a)(4)J The Tomophase OCTIS is an imaging tool for the evaluation of human tiss… | 2004 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | 2011 | 9 |
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 16 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112770 (Ninepoint Medical, Inc., 2011) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K033783.
How does its category compare?
All NQQ devicesNQQ System, Imaging, Optical Coherence Tomography (Oct): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NQQ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQQ
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQQ
2in 2025
MAUDE reports naming product code NQQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 82 | 1 | 0 |
| 2011 | 2 | — | 1 | 2 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 5 | 91 | 0 | 3 |
| 2016 | 5 | 91 | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 84 | 0 | 6 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 3 | 86 | 0 | 6 |
| 2024 | 2 | — | 0 | 6 |
| 2025 | 8 | 146 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Tomophase OCTIS (Optical Coherence Tomography Imaging System) is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102599: Tomophase Octis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102599
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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