SUZHOU CHINA, Jan. 19, 2018 — UL, a global safety science organization, has issued the first UL Marketing Claim Verification and UL Verified Mark in the field of medical devices to the Ophthalmic Imaging System, manufactured by Visunex Medical System Co., Ltd. out of Suzhou China. The claim tested and measured under the verification program is that the device provides a 130 (degrees) Field of View.
Ophthalmic wide-field fundus cameras are used in hospitals to inspect for and diagnose eye disease. Field of View (FOV) is one of the most critical aspects in retinal diagnosis of newborn babies and is one of the key features of a fundus camera. However, the most common eye diseases, such as retinopathy of prematurity (ROP)[i], are initially present at the very edge of the retina. With the assistance of wide FOV, physicians may be able to sufficiently view the edge area for pathological diagnosis.
“Even in the absence of standards, our technical experts found a way to help our customer demonstrate the truth behind their marketing claim,” said Luke Zhang, Operations Manager, UL Suzhou. “We now have a robust and repeatable Verification program so that physicians and hospitals purchasing these types of products can have confidence that they will be able to see the field as promoted.”
In order to gain approval under the new UL Verification program for Field of View, UL technical experts developed an evaluation plan to measure and test the Visunex fundus camera in UL ISO 17025-accredited test labs. The test program is documented and can be repeated on other products. The Verification Mark claim is valid for one year unless re-tested.
The Ophthalmic Imaging System is registered with the US FDA and China FDA for use in those markets.
For additional information related to product verification for medical devices, visit verify.ul.com or email Medical.Inquiry@ul.com.
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[i] Per the National Eye Institute, ROP is “a blinding eye disorder that primarily affects infants weighing about 2 ¾ pounds or less and born before 31 weeks of gestation.” https://nei.nih.gov/health/rop/rop