Spectral OCT device receives 510(k) clearance from FDA

Depew, NY-Reichert Inc. has received 510(k) clearance from the FDA to market its spectral optical coherence tomography (OCT) system (Optopol SOCT Copernicus) in the United States.

The system, which produces high-resolution, three-dimensional images of the retina, was the first commercially available spectral OCT ophthalmic imaging device in the world market, according to a statement released by the company.

“The introduction of [the system] is a continuation of our growth strategy of adding high-technology, diagnostic instruments to our product portfolio,” said Tim Levindofske, president and chief executive officer of Reichert. The company expects the device to be well received by eye-care physicians in the United States, he added.