# K183320: Ilumien Optis, Optis Integrated, Optis Mobile

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical (Now Abbott Medical)
- Decided: Apr 2, 2019 after 123 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: 10 generations back to K934139 (1995). 55 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160878: OPTIS Metallic Stent Optimization E.4 SW, Lightlab Imaging, Inc. (2016) Summary page 4.
- K133323: Volcano Ifr Modality, Volcano Corporation (2014) Summary page 4.

## Most influential descendants
- K232386: ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 (2023), 0 descendants of its own
- K192267: ILUMIEN System with AptiVue Software version D.3 (2019), 0 descendants of its own

## Indications for use
The OPTIS imaging 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 OPTIS imaging 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/K183320
Methodology: https://510kreport.com/methodology