# K230691: HyperVue™ Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrawave, Inc.
- Decided: Jun 7, 2023 after 86 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.
1 later device descends from it; 1 cites it directly.
1 of 7 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 4.

## Most influential descendants
- K251198: HyperVue™ Software (2025), 0 descendants of its own

## Indications for use
The HyperVue™ Imaging System is intended for the 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. The NIRS capability of the HyperVue™ Imaging System is intended for the detection of lipid core containing plaques of interest. The NIRS capability of the HyperVue™ Imaging System is intended for the assessment of coronary artery lipid core burden. The NIRS capability of the HyperVue™ 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/K230691
Methodology: https://510kreport.com/methodology