Ophthalmic Imaging Systems: FDA Clearance

Ophthalmic Imaging Systems, a leading digital imaging and informatics company, today announced that its revolutionary new portable imaging device, the OIS EyeScan, has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA).

The OIS EyeScan is the only portable imaging device that is capable of imaging both the anterior and posterior segment of the eye. Powered by OIS WinStation Software, and fully integrated with the OIS Symphony Image Management Solution, OIS EyeScan will deliver more functionality than has ever been available in an imaging device. With the ability to capture images from a customized chin rest, from a slit lamp adapter or as a handheld device, the OIS EyeScan is versatile enough to add value to any ophthalmologist's practice. The OIS EyeScan has been designed to be small enough to fit easily in the trunk of a car, and portable enough to be used at multiple locations in one day. For more information, an electronic brochure is available online at http://www.oisi.com/OISEyeScan.

"By receiving FDA 510(k) clearance for the OIS EyeScan, we can now actively market the device to our customers. The OIS EyeScan is already highly anticipated among our customers and we are looking forward to delivering this device to the market," stated Gil Allon, Chief Executive Officer of OIS. "The EyeScan brings an entirely new level of versatility to ophthalmologists' offices, and is unlike any other single diagnostic imaging device ever released."