Device typeCoronary optical coherence tomography system: An assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. It typically consists of a main operator's console which includes a computer for image storage, keyboard/mouse controls, and a visual display unit (VDU); audio recording facilities; and a printer. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography.
FDA categoryCOMPUTER, BLOOD-PRESSURE
Device ID05415067037626
Catalog number1015082
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information