# K111201: C7 XR Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Lightlab Imaging, Inc.
- Decided: Aug 10, 2011 after 103 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: 7 generations back to K003122 (2001). 25 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093857: C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories, Lightlab Imaging, Inc. (2010) Summary page 2.
- K092105: Radianalyzer Xpress, Radi Medical Systems AB (2009) Summary page 3.
- K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver, Radi Medical Systems AB (2008) Summary page 3.

## Most influential descendants
- K150237: ILUMIEN, Drageonfly OPTIS Imaging Catheter (2015), 1 descendant of its own
- K192267: ILUMIEN System with AptiVue Software version D.3 (2019), 0 descendants of its own

## Indications for use
The C7 XRTM Imaging System with C7 DragonflylV Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 DragonflyTM Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 DragonfIyTM 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 C7 XRTM Imaging System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal sortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (PER). The physician may use the PER parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated,

Source page: https://510kreport.com/device/K111201
Methodology: https://510kreport.com/methodology