# K242098: Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Vivolight Medical Device & Technology Co., Ltd.
- Decided: Apr 11, 2025 after 267 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: 4 generations back to K123369 (2013). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150878: Ilumien Optis, Lightlab Imaging, Inc. (2015) Summary page 5.
- K141453: Ilumien Optis, Dragonfly Optis Imaging Catheter, Lightlab Imaging, Inc. (2014) Summary page 5.
- K152120: OPTIS Mobile System, Lightlab Imaging, Inc. (2015) Summary page 5.
- K230411: Dragonfly OpStar™ Imaging Catheter, Abbott Medical (2023) Summary page 5.

## Indications for use
Cornaris Intravascular Imaging System with Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. LumenCross Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The 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 LumenCross Imaging Catheter (referred to as LumenCross) with the Cornaris Intravascular Imaging System produced by Vivolight, which is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The LumenCross intended for use in vessels 2.0~3.5mm in diameter. The LumenCross is not indicated for use in the left main coronary artery or in a target vessel that has undergone a previous bypass procedure.

Source page: https://510kreport.com/device/K242098
Methodology: https://510kreport.com/methodology