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)…
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.
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
Record
Regulatory record for Starlight Imaging Catheter | Listed by | Spectrawave, Inc., United States |
| FDA product code | NQQ |
| Device type | System, Imaging, Optical Coherence Tomography (Oct) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Manufacturer |
| Record published | 2024-02-23 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.