# K123369: Ilumien Optis

- Pathway: 510(k) (Traditional)
- Applicant: Lightlab Imaging, Inc.
- Decided: Jan 30, 2013 after 90 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
No predicates in its family tree.
28 later devices descend from it; 2 cite it directly.
2 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K112001: C7 XRTM Imaging System with Fractional Flow Reserve (FFR) (ILUMIEN Guided Therapy System). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K141769: Optis Integrated System, Dragonfly Optis Imaging Catheter (2014), 22 descendants of its own
- K141453: Ilumien Optis, Dragonfly Optis Imaging Catheter (2014), 14 descendants of its own
- K192019: Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 (2019), 10 descendants of its own
- K151286: OPTIS Integrated System Mobile Workstation (2015), 10 descendants of its own
- K150878: Ilumien Optis (2015), 10 descendants of its own

## Indications for use
The ILUMIEN OPTIS with Dragonfly Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The 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. 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/K123369
Methodology: https://510kreport.com/methodology