510(k) · Cleared
ClearedCornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Vivolight Medical Device & Technology Co., Ltd. · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Apr 11, 2025 as substantially equivalent to K150878 (Lightlab Imaging, Inc., 2015) and 3 other predicates after a 267-day review. Its family tree reaches back 4 generations to 2013. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 11, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K123369 (2013). 8 ancestors in all. No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK123369 Ilumien OptisLightlab Imaging, Inc. · 2013
- 3 generations backK141453 Ilumien Optis, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014
- 2 generations backK150878 Ilumien OptisLightlab Imaging, Inc. · 2015
- 1 generation backK152120 OPTIS Mobile SystemLightlab Imaging, Inc. · 2015
- This deviceK242098 Cornaris Intravascular Imaging System (P80-E); Cornaris…Shenzhen Vivolight Medical Device & Technology Co., Ltd. · 2025
Class I recalls in this family
- K192019 Dragonfly OpStar™ Imaging Catheter, AptiVue™…2 generations back · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K123369 | Ilumien Optis | Lightlab Imaging, Inc. | 2013 | — |
| −3 | K141453 | Ilumien Optis, Dragonfly Optis Imaging Catheter | Lightlab Imaging, Inc. | 2014 | — |
| −2 | K150878 | Ilumien Optis | Lightlab Imaging, Inc. | 2015 | — |
| −1 | K152120 | OPTIS Mobile System | Lightlab Imaging, Inc. | 2015 | — |
| 0 (this device) | K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging… | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 1 |
| 2023 | 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 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? (4)
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 |
|---|---|---|---|
| * | K150878 | Ilumien OptisSummary page 5….1200 Product Code(s) NQQ, DQO | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K150878 ILUMIEN OPTIS NQQ K141453 DRAGONFLY OPTIS IMAGING CATHETER DQO K152120 OPTIS Mobile System NQQ K230411 Dragonfly OpStar Imaging C… | 2015 |
| * | K141453 | Ilumien Optis, Dragonfly Optis Imaging CatheterSummary page 5…DQO | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K150878 ILUMIEN OPTIS NQQ K141453 DRAGONFLY OPTIS IMAGING CATHETER DQO K152120 OPTIS Mobile System NQQ K230411 Dragonfly OpStar Imaging Catheter DQO Device Descrip… | 2014 |
| * | K152120 | OPTIS Mobile SystemSummary page 5…CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K150878 ILUMIEN OPTIS NQQ K141453 DRAGONFLY OPTIS IMAGING CATHETER DQO K152120 OPTIS Mobile System NQQ K230411 Dragonfly OpStar Imaging Catheter DQO Device Description Summary 21 CFR 807.92(a)(4) Cornaris In… | 2015 |
| * | K230411 | Dragonfly OpStar™ Imaging CatheterSummary page 5…dicate Trade Name (Primary Predicate is listed first) Product Code K150878 ILUMIEN OPTIS NQQ K141453 DRAGONFLY OPTIS IMAGING CATHETER DQO K152120 OPTIS Mobile System NQQ K230411 Dragonfly OpStar Imaging Catheter DQO Device Description Summary 21 CFR 807.92(a)(4) Cornaris Intravascular Imaging System are c… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K192019Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1Abbott Medical · 2019 · 2 generations back · ◆ in the 2019 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 8 ancestors has a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K150878.
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. 2025, 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?
Cornaris Intravascular Imaging System with Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. LumenCross Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The 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 LumenCross Imaging…
Read the full statement (143 words)
Cornaris Intravascular Imaging System with Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. LumenCross Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The 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 LumenCross Imaging Catheter (referred to as LumenCross) with the Cornaris Intravascular Imaging System produced by Vivolight, which is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The LumenCross intended for use in vessels 2.0~3.5mm in diameter. The LumenCross is not indicated for use in the left main coronary artery or in a target vessel that has undergone a previous bypass procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242098: Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242098
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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