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HyperVue Imaging System

FDA UDI

Class II (US FDA UDI)

by Spectrawave, Inc.

Identity

Trade Name
HyperVue Imaging System FDA UDI
Generic Name
Coronary optical coherence tomography system FDA UDI
Device Name
The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system. The SpectraWAVE Imaging System consists of the following components: • Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface. • Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data. • Controller: A tethered controller that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console. • Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath. FDA UDI
Model / Reference
931 FDA UDI
Description
The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system. The SpectraWAVE Imaging System consists of the following components: • Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface. • Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data. • Controller: A tethered controller that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console. • Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath. FDA UDI

Identifiers

Catalog Number
931 FDA UDI
Primary DI / UDI-DI
00860008045515 FDA UDI
FDA Product Code
NQQ FDA UDI
ORD FDA UDI
OGZ FDA UDI
IYO FDA UDI
GMDN Term
Coronary optical coherence tomography system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
870.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Coronary optical coherence tomography systemIntravascular near-infrared spectroscopy imaging system

HyperVue Imaging System by Spectrawave, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary optical coherence tomography system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectrawave, Inc.

Sources (1)

  • FDA UDI eb8c07b4-0b89-4a90-8340-0ff5b3af01e5 36 fields · synced May 30, 2026