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Topcon receives FDA approval for imaging platform
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PARAMUS, N.J. - Topcon Medical Systems announced it received clearance from the U.S. Food and Drug Administration for its new 3D OCT-2000 macula and optic nerve imaging system, the company announced in a press release.
"The 3D OCT-2000 was designed to provide the benefits needed in a real-world clinical practice," Katrin Teigeler, Topcon vice president of marketing, said in the release. "It unites superb image quality and high performance with unique practical features to improve workflow while providing deep diagnostic insights."
The 3D OCT-2000, a successor to the 3D OCT-1000 platform, can be integrated within a clinical or academic network, with direct interface to electronic medical record systems and Topcon's EyeRoute Ophthalmic Image Management System. The instrument integrates three-dimensional optical coherence tomography and digital fundus imaging, the release said.
The device also incorporates enhanced registration and noise reduction software to provide B-scans and three-dimensional images. Used with Topcon's FastMap software, the 3D OCT-2000 allows simultaneous OCT, fundus and thickness map imaging for both eyes on one screen or on serial exams of one eye.
The platform also enables the capture of sequential stereo disc color photos, the release said.