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The HyperVue™ Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Starlight™ Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter. The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure. The NIRS capability of the HyperVue Imaging System is intended for the detection of lipid core containing plaques of interest. The NIRS capability of the HyperVue Imaging System is intended for the assessment of coronary artery lipid core burden. The NIRS capability of the HyperVue Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

The HyperVue™ 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 HyperVue™ 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.

The Spectra WAVE Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The SpectraWAVE Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter. The SpectraWAVE Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure. The NIRS capability of the SpectraWAVE Imaging System is intended for the detection of lipid core containing plaques of interest. The NIRS capability of the SpectraWAVE Imaging System is intended for the assessment of coronary artery lipid core burden. The NIRS capability of the SpectraWAVE Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

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.