# K221257: SpectraWAVE Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrawave, Inc.
- Decided: Feb 28, 2023 after 302 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: 3 generations back to K123369 (2013). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192019: Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1, Abbott Medical (2019) Summary page 4.
- K183599: Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter, Infraredx, Inc. (2019) Summary page 4.

## Most influential descendants
- K230691: HyperVue™ Imaging System (2023), 1 descendant of its own
- K253101: HyperVue™ Imaging System - Integrated (2025), 0 descendants of its own
- K251198: HyperVue™ Software (2025), 0 descendants of its own
- K243016: Starlight Imaging Catheter (2025), 0 descendants of its own

## Indications for use
The SpectraWAVE Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The SpectraWAVE Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter. The SpectraWAVE Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure. The NIRS capability of the SpectraWAVE Imaging System is intended for the detection of lipid core containing plaques of interest. The NIRS capability of the SpectraWAVE Imaging System is intended for the assessment of coronary artery lipid core burden. The NIRS capability of the SpectraWAVE Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

Source page: https://510kreport.com/device/K221257
Methodology: https://510kreport.com/methodology