Genoray completes Standard X-ray Divas FDA 510(k)
Genoray Co., Ltd. (CEO Park Byung-wook), a global image diagnosis medical device company, announced on the 14th that Dental X-ray Divas (DVAS) completed a pre-marketing report (510(k)) from
FDA 510(k) is the FDA's licensing system that verifies that the pre-marketing performance of medical devices is safe and effective, and with the completion of the pre-marketing report, two types of mobile-type Divas-M and wall-mounted-type Divas-W (DVAS-W) will enter the North American market in earnest.
DVAS is a Genoray steady seller product that has been steadily loved in the dental X-ray market and is an X-ray equipment that implements a clear image using a 0.4mm focal point of 70kV of tube voltage. It provides an intuitive interface of the operation panel through the LCD display and adopts triple joint Arm, allowing you to adjust the top and bottom of the slide with little force. In particular, flexible movement is possible even in a narrow space, so you can easily take pictures without much effort.
"The completion of the FDA's pre-marketing report is an opportunity for the safety and effectiveness of Genoray technology to be recognized internationally, and it will serve as an opportunity to further strengthen global competitiveness," a Genoray official said. "We will continue to expand our portfolio of medical device businesses in overseas markets by completing FDA 510 (k) following the mobile C-Arm Oscar to the dental PSP scanner and DVAS."
Meanwhile, Genoray is a company founded in 2001 and is equipped with various imaging equipment such as Mobile C-Arm, Digital Mammography, dental CBCT, and ultra-lightweight Portable X-ray system. Through a total of five overseas subsidiaries (US, Germany, China, Japan, Turkiye) and 45 global partners, Genoray exports products to more than 80 countries around the world, with 74% of sales coming from overseas.