# K192267: ILUMIEN System with AptiVue Software version D.3

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Dec 17, 2019 after 118 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: 11 generations back to K934139 (1995). 79 ancestors in all.
No later device cites it as a predicate yet.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150237: ILUMIEN, Drageonfly OPTIS Imaging Catheter, Lightlab Imaging, Inc. (2015) Summary page 4.
- K183320: Ilumien Optis, Optis Integrated, Optis Mobile, St. Jude Medical (Now Abbott Medical) (2019) Summary page 4.

## Indications for use
The ILUMIEN™ system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The ILUMIEN system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

Source page: https://510kreport.com/device/K192267
Methodology: https://510kreport.com/methodology