Spectrawave, Inc. · Class II · Cleared Dec 15, 2025
| K-number | K253101 |
| Device name | HyperVue Imaging System - Integrated |
| Applicant | Spectrawave, Inc. |
| Product code | NQQ |
| Device class | Class II |
| Decision date | Dec 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1560 |
The HyperVue Imaging System – Integrated is a stationary, capital equipment platform for intravascular optical imaging of coronary arteries. It combines Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) to simultaneously assess vessel composition and structure, enabling detection of lipid-core plaques and identification of high-risk plaques in patients undergoing coronary interventions.
The subject device has the same intended use, indications, functionality, and operating principles as the predicate device (K221257). The key difference is the configuration: the subject device is fixed and installed in a catheterization lab, whereas the predicate is a mobile cart with braking. Both use the same HyperVue Software (K251198) and compatible Starlight Imaging Catheter (K243016), with identical linear motion (60–120 mm/s), rotational motion (12,000 rpm), touch-screen monitors, and operating conditions.
Design verification and validation were performed in compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, and IEC 60825-1. Bench testing evaluated all device functions at unit, integration, and system levels. Usability evaluation was conducted per ANSI/AAMI/IEC 62366-1.
The HyperVue Imaging System – Integrated is substantially equivalent because it has identical intended use, indications, functionality, and operating principles as the predicate device. Differences in form factor (fixed versus mobile) do not raise new safety or effectiveness concerns. The device passed all required EMC, electrical safety, bench, and usability testing and was found safe and effective for its intended users and use environments.
View the full FDA submission: accessdata.fda.gov