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Starlight Imaging Catheter

FDA UDI

Class II (US FDA UDI)

by Spectrawave, Inc.

Identity

Trade Name
Starlight Imaging Catheter FDA UDI
Generic Name
Intravascular near-infrared spectroscopy imaging system catheter 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. • Catheter Interface Unit (CIU): A tethered CIU 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
951 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. • Catheter Interface Unit (CIU): A tethered CIU 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
951 FDA UDI
Primary DI / UDI-DI
00860008045508 FDA UDI
FDA Product Code
NQQ FDA UDI
ORD FDA UDI
OGZ FDA UDI
IYO FDA UDI
GMDN Term
Intravascular near-infrared spectroscopy imaging system catheter 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Starlight Imaging Catheter 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 catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectrawave, Inc.

Sources (1)

  • FDA UDI 16cfd144-aac0-482e-b9a8-6e69fedea170 35 fields · synced Jun 1, 2026