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news.Opko Health, a specialty healthcare company, has received 510(k) clearance from the FDA to begin marketing its Spectral OCT SLO combination imaging system in the US.
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The Spectral OCT SLO combination imaging system is currently marketed internationally by the company’s subsidiary, Opko Instrumentation.
According to the company, the Spectral OCT SLO is a non-contact, high-resolution non-invasive tomographic and confocal imaging device indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures including: retina, macula, retina nerve fiber layer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye.
Jane Hsiao, vice chairman and chief technical officer of Opko Health, said: “We are pleased to receive 510(k) clearance for the OPKO Spectral OCT SLO combination imaging system. We believe that the high image quality produced by our Spectral OCT SLO and its versatile user-friendly interface offer the clinician a valuable tool for the detection and visualization of ocular pathologies.”