Device typeDermatological optical coherence tomography system: An assembly of devices designed to use a broad-bandwidth light beam aimed via an applicator at a region of interest (ROI) on the surface of the skin for optical coherence tomography (OCT) to provide high-resolution images (e.g., above 1 micron) of the surface tissue in order to visualize skin morphology. It typically consists of a main unit with an operator's console, a computer for image storage, a hand-held or electromechanical probe (applicator), and a visual display unit (VDU). Reflected light is picked up by the probe that converts it into electrical signals. The computer and dedicated software provide cross-sectional images of the derma or two- or three-dimensional (3-D) volume scans.
FDA categorySystem, Imaging, Optical Coherence Tomography (Oct)
Device ID00754016215018
Catalog numberASY-2000
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information