Pediatric and Perioperative*
New image-guided SDOCT featuring integrated color fundus
SDOCT visualization tool enables non-destructive, high precision, full device metrology
*This product is cleared by the FDA for the following Intended Use:
Bioptigen SDOIS is intended to acquire, process, display and save depth-resolved images of Ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The Envisu SDOIS is indicated for use as an aid in the diagnosis of physiological and pathologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient population from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in upright or supine imaging, handheld or mounted, and is suited for imaging patients under anesthesia.
CL-01-06 Rev. B.