The FDA has granted 510(k) clearance to a new digital fundus camera (TRC-NW7SF Mark II, Topcon Medical Systems), according to its manufacturer.
-The FDA has granted 510(k) clearance to a new digital fundus camera (TRC-NW7SF Mark II, Topcon Medical Systems), according to its manufacturer. The company has begun marketing the device and plans a formal launch at this year’s American Academy of Ophthalmology annual meeting.
The camera combines mydriatic and non-mydriatic functions in a single device that is designed to capture retinal images through dilated as well as undilated pupils with high-quality results. According to the company, it can be used to perform various documentation procedures, including intravenous fluorescein angiography, and non-mydriatic, full-color retinal screening for diseases such as diabetic retinopathy and glaucoma.
Users can connect via the company’s image management system (EyeRoute) to view, compare, organize, annotate, and share information collected with the camera. Through the Web-browser interface, images and data can be accessed at any time from any location via the Internet.
“Until now, most retinal cameras have been specifically manufactured to be operated by a highly trained photographer,” said Lon Dowell, Topcon’s director of marketing for imaging products. “But now we can bridge the gap in staff training to provide for the needs of a growing patient population and give the comprehensive ophthalmologist a better tool to help diagnose and treat many sight-threatening illnesses.”