# K093857: C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lightlab Imaging, Inc.
- Decided: Apr 30, 2010 after 135 days
- Product code: NQQ (System, Imaging, Optical Coherence Tomography (Oct))
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921750 (1992). 5 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980851: Galaxy Intravascular Ultrasound System, Model I5028, Boston Scientific Corp (1998) Summary page 2.
- K010707: Atlantis SR Plus Coronary Imaging Catheter, Model 35975, Boston Scientific, Target (2001)

## Most influential descendants
- K140185: Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console (2014), 7 descendants of its own
- K152275: Pantheris System (2015), 6 descendants of its own
- K153460: Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) (2016), 5 descendants of its own
- K160827: Pantheris Catheter (2016), 4 descendants of its own
- K162326: Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled (2016), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K093857
Methodology: https://510kreport.com/methodology