510(k) FDA clearance

Topcon Medical Systems has received 510(k) clearance from the FDA for its DRI OCT Triton Series

510(k) FDA clearance
Colin Kerr
Colin Kerr
Published: Friday, June 1, 2018
Topcon Medical Systems has received 510(k) clearance from the FDA for its DRI OCT Triton Series. “The DRI OCT Triton features exceptionally easy image capture and a 1 micron, 1050nm light source with a scanning speed of 100,000 A-scans/second,” said a company spokesman. In a press release announcing the FDA 510 k clearance, Topcon said that in addition to anterior segment scanning, the DRI OCT Triton can visualise deeper pathology, rapidly penetrating ocular tissues such as the choroid and even the sclera, without being obscured by media opacities or haemorrhage. “The DRI OCT Triton can visualise from vitreous through to sclera at the press of a single button with high sensitivity and speed. The instantaneous capture of a high-density data cube, comprised of 512 B-scans, reduces interpolation between slices and allows the most revealing imagery,” according to Topcon. www.topcon-medical.eu
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