510(k) · Cleared
ClearedC7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories
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 Apr 30, 2010 as substantially equivalent to K980851 (Boston Scientific Corp, 1998) and 1 other predicate after a 135-day review. Its family tree reaches back 2 generations to 1992. 11 later devices descend from it.
- Decided
- Apr 30, 2010
- Review
- 135 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K921750 (1992). 5 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
- 1 generation backK980851 Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp · 1998
- This deviceK093857 C7 XR Imaging System with C7 Dragonfly Imaging Catheter and…Lightlab Imaging, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK140185 Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK152275 Pantheris SystemAvinger, Inc. · 2015
- Descendant · 3 generations on · 5 of its ownK153460 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. · 2016
- Descendant · 4 generations on · 4 of its ownK160827 Pantheris CatheterAvinger, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK162326 Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014 · cites it directly7descendants
- K152275Pantheris SystemAvinger, Inc. · 2015 · 2 generations on6descendants
- K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. · 2016 · 3 generations on5descendants
- K160827Pantheris CatheterAvinger, Inc. · 2016 · 4 generations on4descendants
- K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921750 | Cvis Insight Iii System | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −1 | K980851 | Galaxy Intravascular Ultrasound System, Model I5028 | Boston Scientific Corp | 1998 | — |
| 0 (this device) | K093857 | C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable… | Lightlab Imaging, Inc. | 2010 | — |
| +1 | K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console | Avinger, Inc. | 2014 | — |
| +2 | K152275 | Pantheris System | Avinger, Inc. | 2015 | — |
| +3 | K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | Avinger, Inc. | 2016 | — |
| +4 | K160827 | Pantheris Catheter | Avinger, Inc. | 2016 | — |
| +2 | K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | Avinger, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K980851 | Galaxy Intravascular Ultrasound System, Model I5028Summary page 2…Cardiovascular 3 PREDICATE DEVICES The predicate devices are the Boston Scientific Galaxy Intravascular Ultrasound System cleared under premarket notification K98085 1 and the Atlantisim SR Pro Coronary Imaging Catheter cleared under premarket notification KO 10707. Together the predicate devices… | 1998 |
| * | K010707 | Atlantis SR Plus Coronary Imaging Catheter, Model 35975 | 2001 |
What descends from it? (11)
See all 112 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 18 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K140185 (Avinger, Inc., 2014) has gone furthest, with 7 descendants of its own.
- 6 other devices also cite its predicate K980851.
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 C7 XR™ Imaging System with C7 Dragonfly™ 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™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093857 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093857: C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093857
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