February 15, 2013
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iCam fundus camera gains 510(k) clearance
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The U.S. Food and Drug Administration has cleared the iCam non-mydriatic compact fundus camera from Optovue, according to a company news release.
The device, which offers joystick control, image review and electronic medical record communications, can produce 45° color fundus images of the eye and external structures.
The camera features a 12-bit charge-coupled device sensor and an LED light source that reduces energy directed at the eye and increases the camera’s life, according to the release.
Optovue intends to release the iCam on the U.S. market early in the second quarter, the release said. A global release will follow.