Fundus camera gets 510(k) clearance

Fremont, CA- Optovue has received 510(k) clearance for the iCam Non-Mydriatic compact fundus camera. The iCam camera produces 45° color fundus images of the eye as well as external ocular structures.

The iCam includes a variety of functions and features that produce high-quality image documentation and management of ocular health. A 12-bit CCD sensor is used to provide deep, rich colors with lower noise than typical 8-bit CMOS sensors used in competing cameras. An LED light source is used for reduced peak light energy to the eye as well as longer life.

“In our clinic, we believe that the clearance of [the camera] is a game changer, as it gives any clinician the opportunity to do high-quality, easy-to-use fundus photography of various pathologies,” said Jorge Cuadros, OD, of Buena Vista Eyecare Group, San Jose, CA. “In addition, it has an economical pricing structure and unparalleled imaging capabilities with a learning curve that is minimal compared [with] that of other devices.”

Optovue expects to release the iCam to the United States market early in the second quarter, followed by a global release.

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