# Spectrawave, Inc. (manufacturer, Bedford, MA): 17 new FDA device listings, incl. system, imaging, optical coherence tomography (oct)

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Spectrawave, Inc. |
| Owner / operator | Philips Medical Systems International BV |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Bedford, MA, US |
| New listings | 17 |
| Devices | System, Imaging, Optical Coherence Tomography (Oct); Optical Coherence Tomography, Intravascular Catheter; Catheter, Intravascular, Plaque Morphology Evaluation; System, Imaging, Pulsed Echo, Ultrasonic; System, Image Processing, Radiological; X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device |
| Product codes | NQQ, ORD, OGZ, IYO, LLZ, QHA |
| Device classes | Class II |
| Medical specialties | Radiology, Cardiovascular |
| Brand names | HyperVue Imaging System; X1-FFR; HyperVue™ Imaging System - Integrated; Starlight Imaging Catheter; HyperVue Software |
| First new listing | 2026-06-16 |
| Latest new listing | 2026-06-16 |
| FDA registration number | 3017654247 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.