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Starlight Imaging Catheter

Spectrawave, Inc. · Model 951 · UDI-DI 00860008045508

510(k) clearances

Adverse events

Recalls

Facilities

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.

Recalls

Date	Firm	Reason
2018-04-11	Ninepoint Medical Inc.	Distal tips of the probes may detach from the probe shaft during use.
2011-12-22	Imalux Corporation	During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.
2010-07-20	Optovue Inc.	Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.