# K253101: HyperVue™ Imaging System - Integrated

- Pathway: 510(k) (Traditional)
- Applicant: Spectrawave, Inc.
- Decided: Dec 15, 2025 after 82 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
The HyperVue ™ Imaging System - Integrated with compatible HyperVue ™ Software and Starlight ™ Imaging Catheter 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 - Integrated is intended for the detection of lipid core containing plaques of interest. The NIRS capability of the HyperVue Imaging System - Integrated is intended for the assessment of coronary artery lipid core burden. The NIRS capability of the HyperVue Imaging System - Integrated is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

Source page: https://510kreport.com/device/K253101
Methodology: https://510kreport.com/methodology