# K243016: Starlight Imaging Catheter

- Pathway: 510(k) (Special)
- Applicant: Spectrawave, Inc.
- Decided: Mar 20, 2025 after 174 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). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221257: SpectraWAVE Imaging System, Spectrawave, Inc. (2023) Summary page 5.

## Indications for use
Starlight Imaging Catheter with HyperVue Imaging System is intended for imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Starlight Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter. The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

Source page: https://510kreport.com/device/K243016
Methodology: https://510kreport.com/methodology