Topcon's DRI OCT TritonTM Series Receives 510(k) Clearance

      Becomes the First Commercially Available Multi-modal Swept Source OCT in the U.S
 

OAKLAND, NJ, January 22, 2018 – Topcon Medical Systems (TMS) of Oakland, NJ is proud to announce that its DRI OCT Triton Series has received 510(k) clearance from the FDA.

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. The multi-modal instrument incorporates a built-in retinal camera, eye tracking during capture of selected scans, and combines Topcon's years of expertise in OCT imaging, color, red-free, FA and FAF imaging with the diagnostic power of Swept Source OCT.


In addition to anterior segment scanning, the DRI OCT Triton can visualize deeper pathology, rapidly penetrating ocular tissues such as the choroid and even the sclera, without being obscured by media opacities or hemorrhage. The DRI OCT Triton can visualize 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.


The instrument also features widefield OCT scanning (12 mm x 9 mm) with reference database which is useful in annual exams, allowing fully automated mapping and illustration of both the macula and optic disc in one single scan and potentially halving the number of scans the patient requires. It displays high-resolution fundus images with clear retinal vessel and macular mapping to allow Pin- PointTM Registration of the deepest pathology. Page 2 of 2


“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,” said Richard Spaide, MD, Vitreous Retina Macula Consultants of New York.


“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 visualization of the entire tomogram, allowing for a better understanding of many ocular pathologies and enhancing the standard of patient care,” stated John Fujita, President of Topcon Medical Systems.


The new DRI OCT Triton Series will be on display at the following upcoming shows: International Retinal Imaging Symposium (IRIS) on Feb. 20th in Los Angeles, CA and American Glaucoma Society (AGS) on March 1st - 4th in New York, NY. For more information, please visit us at one of these shows or go to www.topconmedical.com

About Topcon Medical Systems, Inc.
Based in Oakland, NJ, Topcon Medical Systems (TMS) is a leader and technical innovator in the field of ophthalmic instrumentation. For more than 40 years, TMS has offered the most complete and technically advanced line of ophthalmic equipment in the U.S. marketplace. This equipment comprises the largest selection of precision ophthalmic and optical instruments from one manufacturer, providing a complete range of products for general and specialized applications. TMS manages ophthalmic dealer sales, corporate sales, and government sales. TMS is a subsidiary of Topcon America Corporation, a wholly owned subsidiary of Topcon Corporation of Tokyo, Japan.
 

Topcon's DRI OCT TritonTM 系列獲得510（k）許可

成為美國首個可商用的多模式Swept Source OCT

OAKLAND, NJ, January 22, 2018 – Topcon Medical Systems (TMS) of Oakland, NJ

自豪地宣布其DRI OCT Triton系列已獲得FDA的510（k）許可。

 

DRI OCT Triton具有非常容易的影像拍攝功能以及1微米，1050nm的光源，掃描速度為每秒100,000次A-scans。 儀器包括多種拍攝模式及內置眼底照相機，拍攝期間自動追蹤眼睛掃描，並結合Topcon在OCT成像方面的多年專業知識，色彩，red-free，FA和FAF影像與Swept Source OCT診斷領域的權威。
 

除了前房掃描外，DRI OCT Triton還可看見更深層的病理，從脈絡膜甚至到鞏膜，掃描迅速的穿透眼部組織，而不會被渾濁或出血的介質遮擋。DRI OCT Triton 只需按一個按鈕就能以高靈敏度與高速的掃描看見玻璃體到鞏膜。瞬間攝取大量的數據體，由512次B-scans組成，可減少每張B-scan之間的插值並最顯示出最好的影像。
 

該儀器還具有數據database與較大OCT掃描範圍（12 mm x 9 mm）這在年度健檢中非常有用，單次拍攝即可全自動繪製出黃斑部與視盤的報告，並且至少降低患者一半的拍攝次數。它顯示高分辨率眼底圖像，和清晰的視網膜血管和黃斑圖如針尖般精準定位出最深層的病症。

 

“Swept source OCT影像在實踐中大大提高了我的診斷能力。 Topcon DRI OCT Triton操作簡單，可從玻璃體至鞏膜提供統一的詳細信息，甚至更遠。Topcon Triton在一台機器上提供非常多的拍攝模式功能，多種成像的模式有助於未來的全方位診斷，”玻璃體視網膜黃斑病醫師Richard Spaide, Vitreous Retina Macula Consultants of New York表示


 

“我們非常高興地宣布DRI OCT Triton、DRI OCT和DRI Triton Plus最近獲得FDA批准。 Triton系列具有真實的彩色眼底照相機和大範圍OCT掃描能力提供首台具有多模式影像功能的Swept Source OCT。 DRI OCT Triton系列革命性的功能為整個斷層圖提供了出色的可視化效果，可以更好地了解許多眼部疾病，並提高病人醫療標準”Topcon醫療系統總裁John Fujita。