FDA.report

SPECTRAWAVE, INC.

Matched from indexed company URL: Spectrawave, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30176542473017654247SPECTRAWAVE, INC.1N2026-01-0112 Oak Park Drive Bedford MA US 01730

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00860008045508Starlight Imaging Catheter - 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.3234016480ashah@spectrawave.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3034391781284821K253101HyperVue™ Imaging System - IntegratedNQQ2025-12-15
3034391045591926K251355X1-FFRQHA2025-10-17
3034391838702748K251198HyperVue™ SoftwareNQQ2025-07-16
3034391635364408K243016Starlight Imaging CatheterNQQ2025-03-20
3034391663224876K221257SpectraWAVE Imaging SystemNQQ2023-02-28
3034391469298082
3034391827323530
3034392060142527

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NQQ42025-12-15
QHA12025-10-17

PMN

GUDID

Starlight Imaging Catheter - 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.

Spectrawave, Inc.

2024-02-23

HyperVue Imaging System - 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.

Spectrawave, Inc.

2024-02-23