EnFocus 2300 Integrated OCT System - Spectral-domain optical coherence tomography system

Intended purpose

The EnFocus 2300 Integrated OCT System is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The EnFocus 2300 Integrated OCT System is indicated for use as an aid in the visualization of physiologic and pathologic conditions of the eye through non-contact optical imaging. The EnFocus 2300 Integrated OCT System is indicated for use on patient populations from premature and neonatal infants to adult. The EnFocus 2300 Integrated OCT System is indicated for use in supine imaging, mounted to a surgical microscope, with cooperative patients or patients under anesthesia.