510(k) · Cleared
ClearedIlumien Optis, Dragonfly Optis Imaging Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightlab Imaging, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Sep 19, 2014 as substantially equivalent to K123369 (Lightlab Imaging, Inc., 2013) after a 109-day review. Its family tree reaches back 1 generation to 2013. 1 of the 16 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Sep 19, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123369 (2013). 14 later devices descend from it, 5 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK123369 Ilumien OptisLightlab Imaging, Inc. · 2013
- This deviceK141453 Ilumien Optis, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK150878 Ilumien OptisLightlab Imaging, Inc. · 2015
- Descendant · 2 generations on · 9 of its ownK152120 OPTIS Mobile SystemLightlab Imaging, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK192922 Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC · 2020
- Descendant · 3 generations on · 3 of its ownK160878 OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK230620 Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K172258 Novasight Hybrid Systemcites it directly · 2018
Most influential descendants
Showing 5 of 14 · See all- K150878Ilumien OptisLightlab Imaging, Inc. · 2015 · cites it directly10descendants
- K152120OPTIS Mobile SystemLightlab Imaging, Inc. · 2015 · 2 generations on9descendants
- K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC · 2020 · cites it directly3descendants
- K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc. · 2016 · 3 generations on3descendants
- K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123369 | Ilumien Optis | Lightlab Imaging, Inc. | 2013 | — |
| 0 (this device) | K141453 | Ilumien Optis, Dragonfly Optis Imaging Catheter | Lightlab Imaging, Inc. | 2014 | — |
| +1 | K150878 | Ilumien Optis | Lightlab Imaging, Inc. | 2015 | — |
| +2 | K152120 | OPTIS Mobile System | Lightlab Imaging, Inc. | 2015 | — |
| +1 | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | Gentuity, LLC | 2020 | — |
| +3 | K160878 | OPTIS Metallic Stent Optimization E.4 SW | Lightlab Imaging, Inc. | 2016 | — |
| +2 | K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 1 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
1 device in this family has 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K123369 | Ilumien OptisSummary page 5…K141453 4. PREDICATE DEVICE x ILUMIEN OPTIS with Dragonfly I Catheter manufactured by LightLab Imaging, Inc. K123369 5. DEVICE DESCRIPTION The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an… | 2013 |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150878 | Ilumien Optis | 2015 | 10 |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | 2020 | 3 |
| K172258 | Novasight Hybrid System Class I | 2018 | 1 |
| K250684 | OPUSWAVE Dual Sensor Imaging System | 2025 | 0 |
| K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System… | 2025 | 0 |
Has anything in its family been recalled? (1 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 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The ILUMIEN OPTIS with C7 Dragonfly, 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 C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the…
Read the full statement (145 words)
The ILUMIEN OPTIS with C7 Dragonfly, 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 C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly, 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/K141453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141453: Ilumien Optis, Dragonfly Optis Imaging Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141453
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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