Topcon ’ s ocular diagnostic instrument lands 510(k) clearance

Topcon Medical Systems said today that its DRI OCT Triton Series system won 510(k) clearance from the FDA. The company’s ocular diagnostic instrument features a built-in retinal camera, eye-tracking and a 1 micron, 1050 nm light source with a scanning speed of 100,000 A-scans/second. Topcon’s touted its system as being able to quickly penetrate ocular tissues without being obscured by hemorrhage or media opacities. It also includes widefield OCT scanning with a reference database. Topcon added that the system displays high-resolution images with clear retinal vessel and macular mapping. “Swept Source OCT imaging massively increases my diagnostic capabilities in practice. The Topcon DRI OCT Triton is simple to operate and provides uniform detailed information from the vitreous through to the sclera, and beyond. The ability of the Topcon Triton to provide so many imaging modalities in one machine is a great advantage to future system-wide diagnostic approaches and directly enables multi-modal imaging approaches,” Dr. Richard Spaide, of Vitreous Retina Macula Consultants, said in prepared remarks. “We are very pleased to announce the recent FDA clearance of the DRI OCT Triton and DRI OCT Triton Plus. With a true color fundus camera and widefield OCT scanning capability, the Triton Series provides the first Swept Source OCT with multi-modal imaging capabilities. The revolutionary features of the DRI OCT Triton Series provides exceptional visualizatio...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Topcon Source Type: news