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 Jul 15, 2015 as substantially equivalent to K141453 (Lightlab Imaging, Inc., 2014) after a 105-day review. Its family tree reaches back 2 generations to 2013. 10 later devices descend from it.
- Decided
- Jul 15, 2015
- Review
- 105 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K123369 (2013). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK123369 Ilumien OptisLightlab Imaging, Inc. · 2013
- 1 generation backK141453 Ilumien Optis, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014
- This deviceK150878 Ilumien OptisLightlab Imaging, Inc. · 2015
- Descendant · cites it directly · 9 of its ownK152120 OPTIS Mobile SystemLightlab Imaging, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK192922 Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC · 2020
- Descendant · 2 generations on · 3 of its ownK160878 OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK230620 Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC · 2023
- Descendant · 3 generations on · 2 of its ownK183320 Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical) · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K152120OPTIS Mobile SystemLightlab Imaging, Inc. · 2015 · cites it directly9descendants
- K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC · 2020 · 2 generations on3descendants
- K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc. · 2016 · 2 generations on3descendants
- K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC · 2023 · 3 generations on2descendants
- K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical) · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K123369 | Ilumien Optis | Lightlab Imaging, Inc. | 2013 | — |
| −1 | K141453 | Ilumien Optis, Dragonfly Optis Imaging Catheter | Lightlab Imaging, Inc. | 2014 | — |
| 0 (this device) | K150878 | Ilumien Optis | Lightlab Imaging, Inc. | 2015 | — |
| +1 | K152120 | OPTIS Mobile System | Lightlab Imaging, Inc. | 2015 | — |
| +2 | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | Gentuity, LLC | 2020 | — |
| +2 | K160878 | OPTIS Metallic Stent Optimization E.4 SW | Lightlab Imaging, Inc. | 2016 | — |
| +3 | K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | 2023 | — |
| +3 | K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | St. Jude Medical (Now Abbott Medical) | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K141453 | Ilumien Optis, Dragonfly Optis Imaging CatheterSummary page 4…Product Code NQQ 3. PREDICATE DEVICE ILUMIEN OPTIS with Dragonfly OPTIS Imaging Catheter manufactured by LightLab Imaging, Inc. K141453 LightLab Imaging, Inc. Traditional 510(k) 3/31/15 ILUMIEN OPTIS… | 2014 |
What descends from it? (10)
2 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?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152120 (Lightlab Imaging, Inc., 2015) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K141453.
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. 2015, 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 DUO or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel…
Read the full statement (139 words)
The ILUMIEN OPTIS with Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly DUO or Dragonfly OPTIS 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/K150878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150878: Ilumien Optis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150878
Report an extraction error
Are you the manufacturer?
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