510(k) · Cleared
ClearedIlumien Optis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightlab Imaging, Inc. · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Jan 30, 2013 after a 90-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 of the 29 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Jan 30, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 1
28 later devices descend from it, 2 citing it directly. 2 of the 29 devices in this family, counting this one, have a Class I recall.
- This deviceK123369 Ilumien OptisLightlab Imaging, Inc. · 2013
- Descendant · cites it directly · 22 of its ownK141769 Optis Integrated System, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014
- Descendant · cites it directly · 14 of its ownK141453 Ilumien Optis, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK192019 Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1Abbott Medical · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK151286 OPTIS Integrated System Mobile WorkstationLightlab Imaging, Inc. · 2015
- Descendant · 2 generations on · 10 of its ownK150878 Ilumien OptisLightlab Imaging, Inc. · 2015
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K141769Optis Integrated System, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014 · cites it directly22descendants
- K141453Ilumien Optis, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014 · cites it directly14descendants
- K192019Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1Abbott Medical · 2019 · 2 generations on10descendants
- K151286OPTIS Integrated System Mobile WorkstationLightlab Imaging, Inc. · 2015 · 2 generations on10descendants
- K150878Ilumien OptisLightlab Imaging, Inc. · 2015 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123369 | Ilumien Optis | Lightlab Imaging, Inc. | 2013 | — |
| +1 | K141769 | Optis Integrated System, Dragonfly Optis Imaging Catheter | Lightlab Imaging, Inc. | 2014 | — |
| +1 | K141453 | Ilumien Optis, Dragonfly Optis Imaging Catheter | Lightlab Imaging, Inc. | 2014 | — |
| +2 | K192019 | Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 | Abbott Medical | 2019 | Class I |
| +2 | K151286 | OPTIS Integrated System Mobile Workstation | Lightlab Imaging, Inc. | 2015 | — |
| +2 | K150878 | Ilumien Optis | Lightlab Imaging, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 1 |
| 2019 | 3 | 1 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 7 | 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.
2 devices in this family have a Class I recall. 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; 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 | K112001 | C7 XRTM Imaging System with Fractional Flow Reserve (FFR) (ILUMIEN Guided… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (28)
See all 282 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K192019Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1Abbott Medical · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K141769 (Lightlab Imaging, Inc., 2014) has gone furthest, with 22 descendants of its own.
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. 2013, 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 ILUMIEN OPTIS with Dragonfly Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The ILUMIEN OPTIS…
Read the full statement (127 words)
The ILUMIEN OPTIS with Dragonfly Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The ILUMIEN OPTIS will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123369: Ilumien Optis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123369
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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