# K141453: Ilumien Optis, Dragonfly Optis Imaging Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Lightlab Imaging, Inc.
- Decided: Sep 19, 2014 after 109 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K123369 (2013). 1 ancestor in all.
14 later devices descend from it; 5 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123369: Ilumien Optis, Lightlab Imaging, Inc. (2013) Summary page 5.

## Most influential descendants
- K150878: Ilumien Optis (2015), 10 descendants of its own
- K152120: OPTIS Mobile System (2015), 9 descendants of its own
- K192922: Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (2020), 3 descendants of its own
- K160878: OPTIS Metallic Stent Optimization E.4 SW (2016), 3 descendants of its own
- K230620: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (2023), 2 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K141453
Methodology: https://510kreport.com/methodology