# K150878: Ilumien Optis

- Pathway: 510(k) (Traditional)
- Applicant: Lightlab Imaging, Inc.
- Decided: Jul 15, 2015 after 105 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 K123369 (2013). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141453: Ilumien Optis, Dragonfly Optis Imaging Catheter, Lightlab Imaging, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K183320: Ilumien Optis, Optis Integrated, Optis Mobile (2019), 2 descendants of its own

## Indications for use
The ILUMIEN OPTIS with 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 Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The 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/K150878
Methodology: https://510kreport.com/methodology