HyperVue Imaging System

Basic Information

• Brand Name: HyperVue Imaging System
• Primary DI: 00860008045515
• Version / Model: 931
• Catalog Number: 931
• Company Name: Spectrawave, Inc.
• Labeler DUNS: 117899663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-23
• Public Version: 1
• Public Version Date: 2024-03-04
• Public Version Status: New
• Public Device Record Key: eb8c07b4-0b89-4a90-8340-0ff5b3af01e5

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	892.1560	2
ORD	Optical Coherence Tomography, Intravascular Catheter	Cardiovascular	870.1200	2
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation	Cardiovascular	870.1200	2
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47490	Coronary optical coherence tomography system	An assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. It typically consists of a main operator's console which includes a computer for image storage, keyboard/mouse controls, and a visual display unit (VDU); audio recording facilities; and a printer. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography.	No	Active
64433	Intravascular near-infrared spectroscopy imaging system	An assembly of optical and computer-based devices designed for intravascular examination of the vasculature (e.g., peripheral vessels, coronary arteries) by means of near-infrared spectroscopy [NIRS] for detection and image-based quantification of lipid core plaques. The system typically consists of an electrically-powered main operator's console with controls/display, and usually a fibreoptic imaging catheter for transmission of the light signals to/from the intravascular site. This device is used during interventional cardiology, radiology, or diagnostic angiography to assess atherosclerotic lesions in patients at risk of developing cardiovascular disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008045515	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius